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Formic acid spiritus (Solution, Spray) Instructions for Use

ATC Code

M02AX10 (Other drugs)

Active Substance

Formic acid (BP British Pharmacopoeia)

Clinical-Pharmacological Group

Analgesic and local anesthetic agent for external use

Pharmacotherapeutic Group

Local irritant

Pharmacological Action

A local irritant agent that exerts a counterirritant effect. It excites the sensitive receptors of the skin, causes vasodilation, and improves tissue trophism.

Indications

Apply as a counterirritant for the symptomatic relief of localized musculoskeletal pain.

  • Use for neuralgia (nerve pain).
  • Use for myalgia (muscle pain).
  • Use for arthralgia (joint pain).

Employ only as part of a complex therapy regimen and not as a sole treatment for the underlying condition.

ICD codes

ICD-10 code Indication
M25.5 Pain in joint
M79.1 Myalgia
M79.2 Neuralgia and neuritis, unspecified
ICD-11 code Indication
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
FB56 Specified soft tissue diseases, not elsewhere classified
FB56.2 Myalgia
ME82 Pain in joint

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.

Apply externally by rubbing into the skin over the painful area. Limit the treatment course to a maximum of 1-2 weeks to prevent local skin irritation and systemic absorption.

Discontinue use if no therapeutic benefit is observed. A repeat course may be initiated only after a break and upon reassessment of the clinical need. Avoid application to large body surface areas.

Solution

For external use. Rub into the skin in the painful area. The course of treatment continues depending on the therapeutic effect, but not more than 1-2 weeks. If necessary, the course can be repeated.

Spray

For external use. Rub into the skin in the area of pain.

Adverse Reactions

Monitor the application site for signs of local skin reactions. The most frequently reported adverse effects are transient and localized.

These include hyperemia (redness), skin itching (pruritus), and allergic reactions such as contact dermatitis. Discontinue use immediately if a severe reaction occurs.

Contraindications

Do not use under any circumstances in the following conditions due to the risk of severe local reactions or increased systemic absorption.

  • Hypersensitivity to formic acid or any component of the formulation.
  • Application to skin with impaired integrity (e.g., cuts, abrasions).
  • Presence of inflammatory skin diseases at the application site (e.g., dermatitis, eczema).
  • Pregnancy and breastfeeding due to potential risks to the fetus or infant.
  • Children and adolescents under 18 years of age, as safety and efficacy are not established.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

Application of the drug to the face, neck, genitals, mucous membranes, and wounds is not allowed.

If this product gets into the eyes, rinse them thoroughly with plenty of water.

After applying this product, wash your hands.

In case of accidental ingestion of the drug, the following are possible: dizziness, headache, nausea, vomiting, gastralgia, impaired cardiovascular function, stimulation or depression of the central nervous system, visual impairment, circulatory collapse, shock, including fatal outcome.

Effect on ability to drive vehicles and machinery

The use of this product does not affect driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Avoid concomitant use with other topical medicinal products applied to the same area. Formic acid may chemically interact with organic compounds, leading to the formation of new chemical entities or denaturation of proteins.

This can alter the efficacy and safety profile of both this product and the other topical agent. Maintain a time interval between applications if combination therapy is unavoidable.

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

Begrif, LLC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 25 mL, 30 mL, 40 mL, 50 mL, or 100 mL bottle or dropper bottle

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) transparent, colorless, with a characteristic odor.

100 g
Formic acid 1.4 g

Excipients: ethanol 70% – 98.6 g.

25 ml – bottles – cardboard packs.
25 ml – dropper bottles – cardboard packs.
25 ml – bottles or dropper bottles 10-200 pcs. – cardboard boxes (for hospitals).
30 ml – bottles – cardboard packs.
30 ml – dropper bottles – cardboard packs.
30 ml – bottles or dropper bottles 10-200 pcs. – cardboard boxes (for hospitals).
40 ml – bottles – cardboard packs.
40 ml – dropper bottles – cardboard packs.
40 ml – bottles or dropper bottles 10-200 pcs. – cardboard boxes (for hospitals).
50 ml – bottles – cardboard packs.
50 ml – dropper bottles – cardboard packs.
50 ml – bottles or dropper bottles 10-200 pcs. – cardboard boxes (for hospitals).
100 ml – bottles – cardboard packs.
100 ml – dropper bottles – cardboard packs.
100 ml – bottles or dropper bottles 10-200 pcs. – cardboard boxes (for hospitals).
0.9 kg – canisters – cardboard packs.
2.7 kg – canisters – cardboard packs.
4.5 kg – canisters – cardboard packs.
9 kg – canisters – cardboard packs.
19 kg – canisters – cardboard packs.
20 kg – canisters – cardboard packs.
30 kg – canisters – cardboard packs.
45 kg – canisters – cardboard packs.

Marketing Authorization Holder

West, LLC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol solution for external use 1.4%: bottle 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) 1.4 % 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Vologda Pharmaceutical Factory, JSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 50 mL bottle

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) transparent, colorless, with a peculiar pungent odor.

100 g
Formic acid 1.4 g

Excipients: ethanol 70%.

50 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Genel RD, LLC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol solution for external use 1.4%: bottle 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) 1.4% 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Ivanovo Pharmaceutical Factory PJSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 30 mL, 50 mL, 80 mL, or 100 mL bottle

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) transparent, colorless, with a peculiar pungent odor.

100 g
Formic acid 1.4 g

Excipients: ethanol 70% – 98.6 g.

30 ml – orange glass bottles (1) – cardboard packs.
50 ml – orange glass bottles (1) – cardboard packs.
80 ml – orange glass bottles (1) – cardboard packs.
100 ml – orange glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Kemerovo Pharmaceutical Factory JSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol solution for external use 1.4%: bottle 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) transparent, colorless, with a peculiar pungent odor.

100 g
Formic acid 1.4 g

Excipients: ethanol 70% – 98.6 g.

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass dropper bottles (1) – cardboard packs.
100 ml – polyethylene terephthalate bottles (1) – cardboard packs.

Marketing Authorization Holder

Kirov Pharmaceutical Factory, SUE (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol solution for external use 1.4%: bottle 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) 1.4% 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Institute Of Medicine And Standardization, LLC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 25 mL, 40 mL, 50 mL, or 100 mL bottle; 100 mL jar

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) transparent, colorless, with a peculiar pungent odor.

100 g
Formic acid 1.4 g

Excipients: ethanol 70% – 98.6 g.

25 ml – glass bottles (1) – cardboard packs.
40 ml – glass bottles (1) – cardboard packs.
50 ml – glass bottles (1) – cardboard packs.
100 ml – glass bottles (1) – cardboard packs.
100 ml – dark glass jars (1) – cardboard packs.

Marketing Authorization Holder

Omsk Pharmaceutical Factory, SUE (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 50 or 100 mL bottle

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) 1.4 % 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Permpharmacy, PJSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol solution for external use 1.4%: bottle 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) 1.4% 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Rostov Pharmaceutical Factory, CJSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 50 or 100 mL bottle

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) 1.4 % 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Salyut, JSC (Russia)

Manufactured By

RFK, CJS (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 20 mL, 30 mL, 40 mL, 50 mL, or 100 mL bottle

Dosage Form, Packaging, and Composition

Solution for external use (alcoholic) 1.4% transparent, colorless, with a peculiar pungent odor.

100 g
Formic acid 1.4 g

Excipients: ethanol 70% – 98.6 g.

25 ml – dark glass bottles (1) – cardboard packs.
30 ml – dark glass bottles (1) – cardboard packs.
40 ml – dark glass bottles (1) – cardboard packs.
50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Tver Pharmaceutical Factory, PJSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol solution for external use 1.4%: bottle 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Alcohol solution for external use 1.4% 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol solution for external use 1.4%: bottle 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Alcohol solution for external use 1.4% 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Usolye-Sibirskiy Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 25 mL, 30 mL, 40 mL, 50 mL, or 100 mL bottle

Dosage Form, Packaging, and Composition

Alcohol solution for external use transparent, colorless, with a specific pungent odor.

100 g
Formic acid 1.4 g

Excipients: ethanol 70% – 98.6 g.

25 ml – bottles (1) – cardboard packs.
30 ml – bottles (1) – cardboard packs.
40 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.

Marketing Authorization Holder

Kopeysk Pharmaceutical Factory, JSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 50 or 100 mL bottle

Dosage Form, Packaging, and Composition

Alcohol solution for external use 1.4 % 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Kopeysk Pharmaceutical Factory, JSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 50 mL bottle

Dosage Form, Packaging, and Composition

Alcohol solution for external use 1.4% 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Kopeysk Pharmaceutical Factory, JSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 50 or 100 mL bottle

Dosage Form, Packaging, and Composition

Alcohol solution for external use 1.4 % 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Flora Kavkaza, JSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 25 mL, 40 mL, 50 mL, 60 mL, 70 mL, 80 mL, 90 mL, or 100 mL bottle

Dosage Form, Packaging, and Composition

Alcohol solution for external use transparent, colorless, with a characteristic odor.

100 g
Formic acid 1.4 g

Excipients: ethanol (ethyl alcohol) 70% – 98.6 g.

25 ml – bottles (1) – cardboard packs.
40 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
60 ml – bottles (1) – cardboard packs.
70 ml – bottles (1) – cardboard packs.
80 ml – bottles (1) – cardboard packs.
90 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
Bottles from 20 to 200 pcs. – group packages (for hospitals).
5 l – canisters for hospitals.
10 l – canisters for hospitals.
20 l – canisters for hospitals.

Marketing Authorization Holder

Formula-FR, LLC (Russia)

Manufactured By

Tula Pharmaceutical Factory, LLC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol solution for external use 1.4%: bottle 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Alcohol solution for external use in the form of a transparent colorless liquid with a characteristic odor.

100 g
Formic acid 1.4 g

Excipients: ethanol 70% (ethyl alcohol) – 98.6 g.

50 ml – orange glass bottles (1) – cardboard packs.
100 ml – orange glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Ecolab, CJS (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol solution for external use 1.4%: bottle 50 ml or 100 ml.

Dosage Form, Packaging, and Composition

Alcohol solution for external use 1.4% 100 g
Formic acid 1.4 g

50 ml – dark glass bottles (1) – cardboard packs.
100 ml – dark glass bottles (1) – cardboard packs.

Marketing Authorization Holder

Ecolab, CJS (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Topical alcohol spray 1.4%: 40 mL or 50 mL bottle, 50 mL dropper bottle.

Dosage Form, Packaging, and Composition

Topical alcohol spray transparent colorless, with a characteristic pungent odor.

1000 g
Formic acid 14 g

Excipients: ethanol (ethyl alcohol 95%) – 662.8 g, purified water – 323.2 g.

40 ml – high-density polyethylene bottles (1) complete with a sprayer – cardboard packs.
50 ml – high-density polyethylene bottles (1) complete with a sprayer – cardboard packs.
40 ml – polyethylene terephthalate bottles (1) complete with a sprayer – cardboard packs.
50 ml – polyethylene terephthalate bottles (1) complete with a sprayer – cardboard packs.
40 ml – brown glass bottles (1) complete with a sprayer – cardboard packs.
50 ml – brown glass bottles (1) complete with a sprayer – cardboard packs.
50 ml – dropper bottles (1) complete with a sprayer – cardboard packs.

Marketing Authorization Holder

Yaroslavl Pharmaceutical Factory, CJSC (Russia)

Dosage Form

Bottle OTC Icon Formic acid spiritus Alcohol 1.4% topical solution: 50 mL bottle

Dosage Form, Packaging, and Composition

Alcohol solution for external use in the form of a transparent, colorless liquid of a specific pungent odor.

100 g
Formic acid (calculated as 100% substance) 1.4 g

Excipients: ethanol (ethyl alcohol) 70% – 98.6 g.

50 ml – orange glass bottles (1) – cardboard packs.

Table of Contents

TABLE OF CONTENTS