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Naphthyzin (Spray, Drops) Instructions for Use

ATC Code

R01AA08 (Naphazoline)

Active Substance

Naphazoline (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Vasoconstrictor drug for topical use in ENT practice

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics

Pharmacological Action

Alpha-adrenomimetic. When applied to the mucous membranes, it has a rapid, pronounced, and prolonged vasoconstrictive effect.

Pharmacokinetics

With topical application, systemic absorption is low.

Indications

For intranasal use: acute rhinitis, allergic rhinitis, sinusitis, eustachitis, laryngitis, laryngeal edema of allergic origin, laryngeal edema due to irradiation, hyperemia of the mucous membrane after operations on the upper respiratory tract, to facilitate rhinoscopy, to stop nosebleeds, to prolong the action of local anesthetics used for superficial anesthesia.

For use in ophthalmology: symptomatic temporary relief of secondary eye hyperemia due to moderate irritant exposure and allergic conjunctivitis.

ICD codes

ICD-10 code Indication
H10.1 Acute atopic (allergic) conjunctivitis
H11.4 Other conjunctival vascular disorders and cysts (conjunctival hyperemia, edema)
H68 Inflammation and obstruction of Eustachian tube
J00 Acute nasopharyngitis (common cold)
J01 Acute sinusitis
J04.0 Acute laryngitis
J30.1 Allergic rhinitis due to pollen
J30.3 Other allergic rhinitis (perennial allergic rhinitis)
J37.0 Chronic laryngitis
J38.4 Edema of larynx
R04.0 Epistaxis
Z51.4 Preparatory procedures for subsequent treatment or examination, not elsewhere classified
ICD-11 code Indication
9A60.01 Acute atopic conjunctivitis
9A60.02 Allergic conjunctivitis
9A60.0Y Other specified papillary conjunctivitis
9A60.0Z Papillary conjunctivitis, unspecified
9A61.4Z Vascular disorders of conjunctiva, unspecified
AB10.Z Diseases of the auditory [eustachian] tube, unspecified
CA00 Acute nasopharyngitis
CA01 Acute rhinosinusitis
CA05.0 Acute laryngitis
CA08.00 Allergic rhinitis due to pollen
CA08.03 Other allergic rhinitis
CA0G Chronic laryngitis or laryngotracheitis
CA0H.3 Edema of larynx
MD20 Epistaxis
QB9A Preparatory procedures for subsequent treatment

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer the 0.05% and 0.1% solutions intranasally or topically in ophthalmology as indicated.

For intranasal use in adults and adolescents over 15 years: instill 1-2 drops or administer 1-2 sprays into each nasal passage. Repeat the procedure every 4-6 hours as needed for nasal congestion relief.

For intranasal use in children aged 6 to 15 years: use only the 0.05% solution. Instill 1 drop or administer 1 spray into each nasal passage. The dosing interval is every 4-6 hours.

For intranasal use in children aged 2 to 6 years: use only the 0.025% solution (prepare by dilution). Instill 1-2 drops into each nasal passage 1-3 times per day. Do not exceed 3 doses in 24 hours.

For topical use in ophthalmology in adults and adolescents: instill 1-2 drops of the 0.05% solution into the conjunctival sac of the affected eye(s). Repeat the application every 3-4 hours as needed to relieve eye redness.

The maximum duration of continuous use for nasal formulations is 5-7 consecutive days. For ophthalmic use, discontinue if no improvement is observed within 72 hours.

Avoid prolonged use to prevent rebound congestion (rhinitis medicamentosa) and systemic absorption. Use the lowest effective dose for the shortest duration necessary to relieve symptoms.

Adverse Reactions

Local reactions: when used in ophthalmology – burning, itching, pain in the eye area; reactive conjunctival hyperemia, visual disturbance, dryness of the nasal mucosa, mydriasis, increased intraocular pressure; with intranasal use – reactive hyperemia, swelling of the nasal mucosa, irritation of the nasal mucosa, with use for more than 1 week – edema of the nasal mucosa, atrophic rhinitis.

Systemic reactions are possible, mainly in children and elderly patients – pallor of the skin, tachycardia, pain in the heart area, increased blood pressure, increased sweating, tremor, headache, agitation, nausea, drowsiness, dizziness.

Contraindications

Hypersensitivity to naphazoline, arterial hypertension, severe atherosclerosis, thyrotoxicosis, chronic rhinitis, atrophic rhinitis, severe eye diseases, angle-closure glaucoma, diabetes mellitus, tachycardia, simultaneous use of MAO inhibitors and the period up to 14 days after their discontinuation; childhood – depending on the dosage form.

With cautioncoronary artery disease, prostatic hyperplasia; pheochromocytoma; pregnancy, breastfeeding period; hyperthyroidism, diabetes mellitus, porphyria, dry rhinitis, dry keratoconjunctivitis, glaucoma; use of other drugs that increase blood pressure.

Use in Pregnancy and Lactation

The use of naphazoline during pregnancy and lactation (breastfeeding) is possible only for strict indications in cases where the expected therapeutic effect for the mother outweighs the potential risk of side effects in the fetus or child.

Pediatric Use

Use in children is possible according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the naphazoline drug labels regarding contraindications for the use of specific naphazoline dosage forms in children of different ages. In children, especially young children, the likelihood of developing systemic adverse reactions to naphazoline is increased.

Geriatric Use

In elderly patients, the likelihood of developing systemic adverse reactions to naphazoline is increased.

Special Precautions

Naphazoline may have a resorptive effect.

With long-term intranasal use, the severity of the vasoconstrictive effect of naphazoline gradually decreases ( tachyphylaxis phenomenon), in connection with which it is recommended to take a break for several days after 5-7 days of use. Prolonged use of the product should be avoided.

If no improvement is observed within 72 hours of using the eye drops, or if irritation or hyperemia increases, or eye pain or visual disturbances appear, the use of the product should be discontinued and a doctor should be consulted. Direct contact of the product with contact lenses should be avoided. It is recommended to remove contact lenses before using eye drops.

Drug Interactions

Should not be used simultaneously with MAO inhibitors or within 14 days after their discontinuation.

Naphazoline slows down the absorption of local anesthetics (prolongs their action during superficial anesthesia).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Alvils, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.05%: dropper bottle 10 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.05% 1 ml
Naphazoline (as nitrate) 500 mcg

10 ml – polypropylene dropper bottles.

Marketing Authorization Holder

Alvils, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: dropper bottle 10 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1% 1 ml
Naphazoline (as nitrate) 1 mg

10 ml – polypropylene dropper bottles.

Marketing Authorization Holder

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.05%: bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.05% 1 ml
Naphazoline 500 mcg

5 ml – bottles (1) with a dropper cap – cardboard boxes.
10 ml – bottles (1) with a dropper cap – cardboard boxes.

Marketing Authorization Holder

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1% 1 ml
Naphazoline 1 mg

5 ml – bottles (1) with a dropper cap – cardboard boxes.
10 ml – bottles (1) with a dropper cap – cardboard boxes.

Marketing Authorization Holder

Aromasintez, LLC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle 10 ml, bottle or dropper bottle 15 ml
Nasal drops 0.05%: bottle 10 ml, bottle or dropper bottle 15 ml

Dosage Form, Packaging, and Composition

Nasal drops as a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – glass bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.


Nasal drops as a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 0.5 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – glass bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle 10 ml, 15 ml, or 20 ml.
Nasal drops 0.05%: bottle 10 ml, 15 ml, or 20 ml.

Dosage Form, Packaging, and Composition

Nasal drops as a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients : boric acid – 20 mg, 0.1M sodium hydroxide solution – to pH 4.5-6.0, purified water – up to 1 ml.

10 ml – polyethylene bottles (1) with a dropper cap – cardboard packs.
15 ml – polyethylene bottles (1) with a dropper cap – cardboard packs.
20 ml – polyethylene bottles (1) with a dropper cap – cardboard packs.


Nasal drops as a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 0.5 mg

Excipients : boric acid – 20 mg, 0.1M sodium hydroxide solution – to pH 4.5-6.0, purified water – up to 1 ml.

10 ml – polyethylene bottles (1) with a dropper cap – cardboard packs.
15 ml – polyethylene bottles (1) with a dropper cap – cardboard packs.
20 ml – polyethylene bottles (1) with a dropper cap – cardboard packs.

Marketing Authorization Holder

Biopharmkombinat, LLC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle or dropper bottle 10 ml or 15 ml
Nasal drops 0.05%: bottle or dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops as a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.


Nasal drops as a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 0.5 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

West, LLC (Russia)

Manufactured By

Samaramedprom, OJSC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle 10 ml or 15 ml, dropper bottle 10 ml or 15 ml
Nasal drops 0.05%: bottle 10 ml or 15 ml, dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops as a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – polymer bottles (1) – cardboard packs.
15 ml – polymer bottles (1) – cardboard packs.
10 ml – dark glass bottles (1) – cardboard packs.
15 ml – dark glass bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.


Nasal drops as a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 0.5 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – polymer bottles (1) – cardboard packs.
10 ml – dark glass bottles (1) – cardboard packs.
15 ml – polymer bottles (1) – cardboard packs.
15 ml – dark glass bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Gerta, LLC (Russia)

Manufactured By

Grotex, LLC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle or dropper bottle 5 ml 1 or 3 pcs., 10 ml or 15 ml 1 pc.
Nasal drops 0.05%: bottle or dropper bottle 5 ml 1 or 3 pcs., 10 ml or 15 ml 1 pc.

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients: boric acid – 20 mg, sea water – 5 mg, 0.1M sodium hydroxide solution – to pH 4.5-6.0, water for injections – to 1 ml.

5 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
5 ml – low-density polyethylene bottles (3) with a dropper – cardboard packs.
10 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
15 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
5 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
5 ml – high-pressure polyethylene dropper bottles (3) – cardboard packs.
10 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
15 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.


Nasal drops in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 0.5 mg

Excipients: boric acid – 20 mg, sea water – 5 mg, 0.1M sodium hydroxide solution – to pH 4.5-6.0, water for injections – to 1 ml.

5 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
5 ml – low-density polyethylene bottles (3) with a dropper – cardboard packs.
10 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
15 ml – low-density polyethylene bottles (1) with a dropper – cardboard packs.
5 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
5 ml – high-pressure polyethylene dropper bottles (3) – cardboard packs.
10 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.
15 ml – high-pressure polyethylene dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

DAV PHARM, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.05%: dropper bottle 10, 15 or 20 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.05% 1 ml
Naphazoline 500 mcg

10 ml – dropper bottles (1) – cardboard boxes.
15 ml – dropper bottles (1) – cardboard boxes.
20 ml – dropper bottles (1) – cardboard boxes.

Marketing Authorization Holder

DAV PHARM, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: dropper bottle 10, 15, or 20 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1% 1 ml
Naphazoline 1 mg

10 ml – dropper bottles (1) – cardboard boxes.
15 ml – dropper bottles (1) – cardboard boxes.
20 ml – dropper bottles (1) – cardboard boxes.

Marketing Authorization Holder

Dalkhimpharm, JSC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: 10 ml bottle or 10 ml dropper bottle.
Nasal drops 0.05%: 10 ml bottle or 10 ml dropper bottle.

Dosage Form, Packaging, and Composition

Nasal drops clear, colorless or light yellow.

1 ml
Naphazoline nitrate 1 mg

Excipients: boric acid – 20 mg, 1M sodium hydroxide solution – to pH 4.5-6.0, water for injections – to 1 ml.

10 ml – bottles (1) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.


Nasal drops clear, colorless or light yellow.

1 ml
Naphazoline nitrate 0.5 mg

Excipients: boric acid – 20 mg, 1M sodium hydroxide solution – to pH 4.5-6.0, water for injections – to 1 ml.

10 ml – bottles (1) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml.
Nasal drops 0.05%: bottle or dropper bottle 10 ml, 15 ml, 20 ml, or 25 ml.

Dosage Form, Packaging, and Composition

Nasal drops a clear, colorless or yellowish liquid.

1 ml
Naphazoline nitrate (naphthyzin) 1 mg

Excipients: boric acid, purified water.

10 ml – bottles (1) – cardboard packs.
10 ml – bottles (9-300) – cardboard boxes (for hospitals).
10 ml – dropper bottles (1) – cardboard packs.
10 ml – dropper bottles (9-300) – cardboard boxes (for hospitals).
15 ml – bottles (1) – cardboard packs.
15 ml – bottles (9-300) – cardboard boxes (for hospitals).
15 ml – dropper bottles (1) – cardboard packs.
15 ml – dropper bottles (9-300) – cardboard boxes (for hospitals).
20 ml – bottles (1) – cardboard packs.
20 ml – bottles (9-300) – cardboard boxes (for hospitals).
20 ml – dropper bottles (1) – cardboard packs.
20 ml – dropper bottles (9-300) – cardboard boxes (for hospitals).
25 ml – bottles (1) – cardboard packs.
25 ml – bottles (9-300) – cardboard boxes (for hospitals).
25 ml – dropper bottles (1) – cardboard packs.
25 ml – dropper bottles (9-300) – cardboard boxes (for hospitals).


Nasal drops a clear, colorless or yellowish liquid.

1 ml
Naphazoline nitrate (naphthyzin) 0.5 mg

Excipients: boric acid, purified water.

10 ml – bottles (1) – cardboard packs.
10 ml – bottles (9-300) – cardboard boxes (for hospitals).
10 ml – dropper bottle (1) – cardboard packs.
10 ml – dropper bottle (9-300) – cardboard boxes (for hospitals).
15 ml – bottles (1) – cardboard packs.
15 ml – bottles (9-300) – cardboard boxes (for hospitals).
15 ml – dropper bottle (1) – cardboard packs.
15 ml – dropper bottle (9-300) – cardboard boxes (for hospitals).
20 ml – bottles (1) – cardboard packs.
20 ml – bottles (9-300) – cardboard boxes (for hospitals).
20 ml – dropper bottle (1) – cardboard packs.
20 ml – dropper bottle (9-300) – cardboard boxes (for hospitals).
25 ml – bottles (1) – cardboard packs.
25 ml – bottles (9-300) – cardboard boxes (for hospitals).
25 ml – dropper bottle (1) – cardboard packs.
25 ml – dropper bottle (9-300) – cardboard boxes (for hospitals).

Marketing Authorization Holder

Lekar, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.05%: 10 ml bottle or 10 ml, 15 ml, 20 ml dropper bottle

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or slightly colored liquid.

100 ml
Naphazoline 0.05 g

Excipients: boric acid 2 g, purified water to 100 ml.

10 ml – polymeric dropper bottles (1) – cardboard packs.
15 ml – polymeric dropper bottles (1) – cardboard packs.
20 ml – polymeric dropper bottles (1) – cardboard packs.
10 ml – bottles (1) – cardboard packs.
10 ml – polymeric dropper bottles – group packaging.
15 ml – polymeric dropper bottles – group packaging.
20 ml – polymeric dropper bottles – group packaging.
10 ml – bottles – group packaging.

Marketing Authorization Holder

Lekar, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: 10 ml bottle or 10 ml, 15 ml, 20 ml dropper bottle

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or slightly colored liquid.

100 ml
Naphazoline 0.1 g

Excipients: boric acid 2 g, purified water to 100 ml.

10 ml – polymeric dropper bottles (1) – cardboard packs.
15 ml – polymeric dropper bottles (1) – cardboard packs.
20 ml – polymeric dropper bottles (1) – cardboard packs.
10 ml – bottles (1) – cardboard packs.
10 ml – polymeric dropper bottles – group packaging.
15 ml – polymeric dropper bottles – group packaging.
20 ml – polymeric dropper bottles – group packaging.
10 ml – bottles – group packaging.

Marketing Authorization Holder

Lekko, CJS (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal spray 0.1%: dropper bottle 15 ml

Dosage Form, Packaging, and Composition

Nasal spray in the form of a clear, colorless or yellowish liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients: boric acid – 20 mg, purified water – to 1 ml.

15 ml – polymeric dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.05%: dropper tube 1.3, 1.5, 2, or 5 ml 1, 2, 4, 5, or 10 pcs., dropper bottle 5 or 10 ml 1 or 2 pcs., bottle with dropper cap 5 ml 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Nasal drops 1 ml
Naphazoline (as nitrate) 500 mcg

1.3 ml – polymeric dropper tubes (1) – cardboard packs.
1.3 ml – polymeric dropper tubes (2) – cardboard packs.
1.3 ml – polymeric dropper tubes (4) – cardboard packs.
1.3 ml – polymeric dropper tubes (5) – cardboard packs.
1.3 ml – polymeric dropper tubes (10) – cardboard packs.
1.5 ml – polymeric dropper tubes (1) – cardboard packs.
1.5 ml – polymeric dropper tubes (2) – cardboard packs.
1.5 ml – polymeric dropper tubes (4) – cardboard packs.
1.5 ml – polymeric dropper tubes (5) – cardboard packs.
1.5 ml – polymeric dropper tubes (10) – cardboard packs.
2 ml – polymeric dropper tubes (1) – cardboard packs.
2 ml – polymeric dropper tubes (2) – cardboard packs.
2 ml – polymeric dropper tubes (4) – cardboard packs.
2 ml – polymeric dropper tubes (5) – cardboard packs.
2 ml – polymeric dropper tubes (10) – cardboard packs.
5 ml – polymeric dropper tubes (1) – cardboard packs.
5 ml – polymeric dropper tubes (2) – cardboard packs.
5 ml – polymeric dropper tubes (4) – cardboard packs.
5 ml – polymeric dropper tubes (5) – cardboard packs.
5 ml – polymeric dropper tubes (10) – cardboard packs.
5 ml – polymeric dropper bottles (1) – cardboard packs.
5 ml – polymeric dropper bottles (2) – cardboard packs.
10 ml – polymeric dropper bottles (1) – cardboard packs.
10 ml – polymeric dropper bottles (2) – cardboard packs.
5 ml – glass bottles (1) complete with a dropper cap – cardboard packs.
5 ml – glass bottles (5) complete with a dropper cap (5) – contour cell packaging (1) made of PVC – cardboard packs.

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: dropper tube 1.3, 1.5, 2, or 5 ml 1, 2, 4, 5, or 10 pcs., dropper bottle 5 or 10 ml 1 or 2 pcs., bottle with dropper cap 5 ml 1 or 5 pcs.

Dosage Form, Packaging, and Composition

Nasal drops 1 ml
Naphazoline (as nitrate) 1 mg

1.3 ml – polymeric dropper tubes (1) – cardboard packs.
1.3 ml – polymeric dropper tubes (2) – cardboard packs.
1.3 ml – polymeric dropper tubes (4) – cardboard packs.
1.3 ml – polymeric dropper tubes (5) – cardboard packs.
1.3 ml – polymeric dropper tubes (10) – cardboard packs.
1.5 ml – polymeric dropper tubes (1) – cardboard packs.
1.5 ml – polymeric dropper tubes (2) – cardboard packs.
1.5 ml – polymeric dropper tubes (4) – cardboard packs.
1.5 ml – polymeric dropper tubes (5) – cardboard packs.
1.5 ml – polymeric dropper tubes (10) – cardboard packs.
2 ml – polymeric dropper tubes (1) – cardboard packs.
2 ml – polymeric dropper tubes (2) – cardboard packs.
2 ml – polymeric dropper tubes (4) – cardboard packs.
2 ml – polymeric dropper tubes (5) – cardboard packs.
2 ml – polymeric dropper tubes (10) – cardboard packs.
5 ml – polymeric dropper tubes (1) – cardboard packs.
5 ml – polymeric dropper tubes (2) – cardboard packs.
5 ml – polymeric dropper tubes (4) – cardboard packs.
5 ml – polymeric dropper tubes (5) – cardboard packs.
5 ml – polymeric dropper tubes (10) – cardboard packs.
5 ml – polymeric dropper bottles (1) – cardboard packs.
5 ml – polymeric dropper bottles (2) – cardboard packs.
10 ml – polymeric dropper bottles (1) – cardboard packs.
10 ml – polymeric dropper bottles (2) – cardboard packs.
5 ml – glass bottles (1) complete with a dropper cap – cardboard packs.
5 ml – glass bottles (5) complete with a dropper cap (5) – contour cell packaging (1) made of PVC – cardboard packs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: dropper bottle 10, 15, or 20 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1% 1 ml
Naphazoline 1 mg

10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.
20 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Ozon, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.05%: dropper bottle 10, 15 or 20 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.05% 1 ml
Naphazoline 500 mcg

10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.
20 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Sintez PJSC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: dropper bottle 10 ml 1 pc.

Dosage Form, Packaging, and Composition

Nasal drops 0.1% clear, colorless or slightly colored.

1 ml
Naphazoline (as nitrate) 1 mg

10 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: dropper bottle 10 ml 1 pc.

Dosage Form, Packaging, and Composition

Nasal drops 0.1% 1 ml
Naphazoline (as nitrate) 1 mg

10 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Slavic Pharmacy, LLC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal spray 0.1%: dropper bottle 10 ml or 15 ml
Nasal spray 0.05%: dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal spray 1 ml
Naphazoline 1000 mcg

10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.


Nasal spray 1 ml
Naphazoline 500 mcg

10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.05%: bottle 5 ml or 10 ml 1 pc.

Dosage Form, Packaging, and Composition

Nasal drops 0.05% 1 ml
Naphazoline (as nitrate) 500 mcg

5 ml – bottles (1) – cardboard packs.
10 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1% 1 ml
Naphazoline (as nitrate) 1 mg

5 ml – bottles (1) – cardboard packs.
10 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.05%: bottle or dropper bottle or jar 5 ml, 10 ml, 15 ml, 20 ml, or 25 ml; dropper tube 2 ml, 10 ml, 15 ml, or 20 ml.

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or almost colorless liquid with a yellowish tint.

1 ml
Naphazoline nitrate 0.5 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

5 ml – bottles* (1) – cardboard packs.
10 ml – bottles* (1) – cardboard packs.
15 ml – bottles* (1) – cardboard packs.
20 ml – bottles* (1) – cardboard packs.
25 ml – bottles* (1) – cardboard packs.
5 ml – dropper bottles (1) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.
15 ml – dropper bottles (1) – cardboard packs.
20 ml – dropper bottles (1) – cardboard packs.
25 ml – dropper bottles (1) – cardboard packs.
2 ml – dropper tubes (1) with a valve – cardboard packs.
10 ml – dropper tubes (1) – cardboard packs.
15 ml – dropper tubes (1) – cardboard packs.
20 ml – dropper tubes (1) – cardboard packs.
5 ml – jars* (1) – cardboard packs.
10 ml – jars* (1) – cardboard packs.
15 ml – jars* (1) – cardboard packs.
20 ml – jars* (1) – cardboard packs.
25 ml – jars* (1) – cardboard packs.

* sealed with polyethylene stoppers and screw-on plastic caps or sealed with polyethylene closure means, or with caps or lids with a dosing pipette, or with an applicator-dispenser or plastic dropper and a cap or lid as a set, or a dropper or dispenser or dosing pipette with a cap or lid, or dropper caps or screw caps with an opening and a dropper as a set, or dropper caps.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle or dropper bottle or jar 5 ml, 10 ml, 15 ml, 20 ml, or 25 ml; dropper tube 2 ml, 10 ml, 15 ml, or 20 ml.

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or almost colorless liquid with a yellowish tint.

1 ml
Naphazoline nitrate 1 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

5 ml – bottles* (1) – cardboard packs.
10 ml – bottles* (1) – cardboard packs.
15 ml – bottles* (1) – cardboard packs.
20 ml – bottles* (1) – cardboard packs.
25 ml – bottles* (1) – cardboard packs.
5 ml – dropper bottles (1) – cardboard packs.
10 ml – dropper bottles (1) – cardboard packs.
15 ml – dropper bottles (1) – cardboard packs.
20 ml – dropper bottles (1) – cardboard packs.
25 ml – dropper bottles (1) – cardboard packs.
2 ml – dropper tubes (1) with a valve – cardboard packs.
10 ml – dropper tubes (1) – cardboard packs.
15 ml – dropper tubes (1) – cardboard packs.
20 ml – dropper tubes (1) – cardboard packs.
5 ml – jars* (1) – cardboard packs.
10 ml – jars* (1) – cardboard packs.
15 ml – jars* (1) – cardboard packs.
20 ml – jars* (1) – cardboard packs.
25 ml – jars* (1) – cardboard packs.

* sealed with polyethylene stoppers and screw-on plastic caps or sealed with polyethylene closure means, or with caps or lids with a dosing pipette, or with an applicator-dispenser or plastic dropper and a cap or lid as a set, or a dropper or dispenser or dosing pipette with a cap or lid, or dropper caps or screw caps with an opening and a dropper as a set, or dropper caps.

Marketing Authorization Holder

Pharmanova, LLC (Russia)

Manufactured By

Biopharmkombinat, LLC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: bottle or dropper bottle 10 ml or 15 ml
Nasal drops 0.05%: bottle or dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline 1 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer bottles (1) – cardboard packs.


Nasal drops in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline 0.5 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer bottles (1) – cardboard packs.

Marketing Authorization Holder

Pharmaceutical Firm LECKO, CJS (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or yellowish tinted liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – polymer dropper bottles (1) with a dropper stopper – cardboard packs.
15 ml – polymer dropper bottles (1) with a dropper stopper – cardboard packs.
10 ml – polymer dropper bottles (1) with an applicator-dispenser – cardboard packs.
15 ml – polymer dropper bottles (1) with an applicator-dispenser – cardboard packs.

Marketing Authorization Holder

Pharmaceutical Firm LECKO, CJS (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Nasal drops 0.05%: dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or yellowish tinted liquid.

1 ml
Naphazoline nitrate 0.5 mg

Excipients : boric acid – 20 mg, purified water – up to 1 ml.

10 ml – polymer dropper bottles (1) with a dropper stopper – cardboard packs.
15 ml – polymer dropper bottles (1) with a dropper stopper – cardboard packs.
10 ml – polymer dropper bottles (1) with an applicator-dispenser – cardboard packs.
15 ml – polymer dropper bottles (1) with an applicator-dispenser – cardboard packs.

Marketing Authorization Holder

Flora Kavkaza, JSC (Russia)

Manufactured By

Flora Kavkaza, JSC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: 10 ml or 15 ml bottle.
Nasal drops 0.05%: 10 ml or 15 ml bottle

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or slightly yellowish tinted liquid.

1 ml
Naphazoline nitrate 0.001 g

Excipients : boric acid – 0.02 g, purified water – up to 1 ml.

10 ml – polymer bottles (1) – cardboard packs.
15 ml – polymer bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer bottles (50) – group packaging (for hospitals).
15 ml – polymer bottles (50) – group packaging (for hospitals).
10 ml – polymer dropper bottles (50) – group packaging (for hospitals).
15 ml – polymer dropper bottles (50) – group packaging (for hospitals).


Nasal drops in the form of a clear, colorless or slightly yellowish tinted liquid.

1 ml
Naphazoline nitrate 0.0005 g

Excipients : boric acid – 0.02 g, purified water – up to 1 ml.

10 ml – polymer bottles (1) – cardboard packs.
15 ml – polymer bottles (1) – cardboard packs.
10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.
10 ml – polymer bottles (50) – group packaging (for hospitals).
15 ml – polymer bottles (50) – group packaging (for hospitals).
10 ml – polymer dropper bottles (50) – group packaging (for hospitals).
15 ml – polymer dropper bottles (50) – group packaging (for hospitals).

Marketing Authorization Holder

YUGPHARM, LLC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Nasal drops 0.1%: dropper bottle 10 ml or 15 ml
Nasal drops 0.05%: dropper bottle 10 ml or 15 ml

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline 0.001 g

Excipients : boric acid – 0.02 g, purified water – up to 1 ml.

10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.


Nasal drops in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline 0.0005 g

Excipients: boric acid – 0.02 g, purified water – up to 1 ml.

10 ml – polymer dropper bottles (1) – cardboard packs.
15 ml – polymer dropper bottles (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Bufus Nasal drops 0.05%: dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.05% 1 ml
Naphazoline 500 mcg

5 ml – polymer dropper bottle (1) – cardboard packs.
10 ml – polymer dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Bufus Nasal drops 0.1%: dropper bottle 5 ml or 10 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1% 1 ml
Naphazoline 1 mg

5 ml – polymer dropper bottle (1) – cardboard packs.
10 ml – polymer dropper bottle (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Bufus Nasal drops 0.05%: 1 ml, 1.5 ml, 2 ml, 5 ml, or 10 ml dropper tube

Dosage Form, Packaging, and Composition

Nasal drops 0.05% 1 ml
Naphazoline 500 mcg

1 ml – polyethylene dropper tube (1) – cardboard packs.
1.5 ml – polyethylene dropper tube (1) – cardboard packs.
2 ml – polyethylene dropper tube (1) – cardboard packs.
5 ml – polyethylene dropper tube (1) – cardboard packs.
10 ml – polyethylene dropper tube (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Naphthyzin Bufus Nasal drops 0.1%: dropper tube 1 ml, 1.5 ml, 2 ml, 5 ml, or 10 ml

Dosage Form, Packaging, and Composition

Nasal drops 0.1% 1 ml
Naphazoline 1 mg

1 ml – polyethylene dropper tube (1) – cardboard packs.
1.5 ml – polyethylene dropper tube (1) – cardboard packs.
2 ml – polyethylene dropper tube (1) – cardboard packs.
5 ml – polyethylene dropper tube (1) – cardboard packs.
10 ml – polyethylene dropper tube (1) – cardboard packs.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Plus Nasal drops 0.1%: bottle 5 ml, 10 ml, 15 ml with dropper
Nasal drops 0.05%: bottle 5 ml, 10 ml, 15 ml with dropper

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients: boric acid – 20 mg, sea water – 5 mg, sodium hydroxide solution 0.1 M – to pH 4.5- 6.0, water for injections – up to 1 ml.

5 ml – bottles with dropper (1) – cardboard packs.
5 ml – bottles with dropper (3) – cardboard packs.
10 ml – bottles with dropper (1) – cardboard packs.
15 ml – bottles with dropper (1) – cardboard packs.


Nasal drops in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 0.5 mg

Excipients: boric acid – 20 mg, sea water – 5 mg, sodium hydroxide solution 0.1 M – to pH 4.5- 6.0, water for injections – up to 1 ml.

5 ml – bottles with dropper (1) – cardboard packs.
5 ml – bottles with dropper (3) – cardboard packs.
10 ml – bottles with dropper (1) – cardboard packs.
15 ml – bottles with dropper (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Renewal Nasal spray 0.1%: bottle 10 ml, 15 ml, or 20 ml
Nasal spray 0.05%: bottle 10 ml, 15 ml, or 20 ml

Dosage Form, Packaging, and Composition

Nasal spray in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients: boric acid, purified water.

10 ml – polyethylene bottles (1) – cardboard packs.
15 ml – polyethylene bottles (1) – cardboard packs.
20 ml – polyethylene bottles (1) – cardboard packs.


Nasal spray in the form of a clear, colorless or slightly colored liquid.

1 ml
Naphazoline nitrate 0.5 mg

Excipients: boric acid, purified water.

10 ml – polyethylene bottles (1) – cardboard packs.
15 ml – polyethylene bottles (1) – cardboard packs.
20 ml – polyethylene bottles (1) – cardboard packs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin Renewal Nasal drops 0.1%: dropper tube 2 ml 1, 2, 5, or 10 pcs., 10 ml, 15 ml, 20 ml, or 25 ml 1 pc.
Nasal drops 0.05%: dropper tube 2 ml 1, 2, 5, or 10 pcs., 10 ml, 15 ml, 20 ml, or 25 ml 1 pc.

Dosage Form, Packaging, and Composition

Nasal drops in the form of a colorless or slightly colored, clear liquid.

1 ml
Naphazoline 1 mg

Excipients: boric acid, purified water.

2 ml – dropper tubes (1) – cardboard packs.
2 ml – dropper tubes (2) – cardboard packs.
2 ml – dropper tubes (5) – cardboard packs.
2 ml – dropper tubes (10) – cardboard packs.
10 ml – dropper tubes (1) – cardboard packs.
15 ml – dropper tubes (1) – cardboard packs.
20 ml – dropper tubes (1) – cardboard packs.
25 ml – dropper tubes (1) – cardboard packs.


Nasal drops in the form of a colorless or slightly colored, clear liquid.

1 ml
Naphazoline 0.5 mg

Excipients: boric acid, purified water.

2 ml – dropper tubes (1) – cardboard packs.
2 ml – dropper tubes (2) – cardboard packs.
2 ml – dropper tubes (5) – cardboard packs.
2 ml – dropper tubes (10) – cardboard packs.
10 ml – dropper tubes (1) – cardboard packs.
15 ml – dropper tubes (1) – cardboard packs.
20 ml – dropper tubes (1) – cardboard packs.
25 ml – dropper tubes (1) – cardboard packs.

Marketing Authorization Holder

Diafarm, JSC (Russia)

Dosage Forms

Bottle OTC Icon Naphthyzin-DIA Nasal drops 0.1%: 10 ml or 15 ml bottle.
Nasal drops 0.05%: 10 ml or 15 ml bottle

Dosage Form, Packaging, and Composition

Nasal drops in the form of a clear, colorless or slightly yellowish liquid.

1 ml
Naphazoline nitrate 1 mg

Excipients: boric acid – 20 mg, purified water – up to 1 ml.

10 ml – dropper bottles (1) – cardboard packs.
15 ml – dropper bottles (1) – cardboard packs.
20 ml – dropper bottles (1) – cardboard packs.


Nasal drops in the form of a clear, colorless or slightly yellowish liquid.

1 ml
Naphazoline nitrate 0.5 mg

Excipients: boric acid – 20 mg, purified water – up to 1 ml.

10 ml – dropper bottles (1) – cardboard packs.
15 ml – dropper bottles (1) – cardboard packs.
20 ml – dropper bottles (1) – cardboard packs.

Table of Contents

TABLE OF CONTENTS