Menthol oil (Solution) Instructions for Use

Marketing Authorization Holder

Tula Pharmaceutical Factory, LLC (Russia)

ATC Code

M02AX10 (Other drugs)

Active Substance

Levomenthol (Rec.INN registered by WHO)

Dosage Forms

	Menthol oil	Solution for topical application and inhalations 1%: 10 ml or 25 ml bottle or dropper bottle.
		Solution for topical application and inhalations 2%: 10 ml or 25 ml bottle or dropper bottle.

Dosage Form, Packaging, and Composition

Solution for topical application and inhalations colorless, oily, with a faint odor of menthol.

Excipients : liquid paraffin 99 g.

10 ml – orange glass bottles (1) – cardboard packs.
25 ml – orange glass bottles (1) – cardboard packs.
10 ml – orange glass dropper bottles (1) – cardboard packs.
25 ml – orange glass dropper bottles (1) – cardboard packs.

Solution for topical application and inhalations colorless, oily, with a faint odor of menthol.

Excipients : liquid paraffin 98 g.

10 ml – orange glass bottles (1) – cardboard packs.
25 ml – orange glass bottles (1) – cardboard packs.
10 ml – orange glass dropper bottles (1) – cardboard packs.
25 ml – orange glass dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with counterirritant action for topical use in ENT practice

Pharmacotherapeutic Group

Other drugs for the treatment of respiratory system diseases

Pharmacological Action

A counterirritant agent; when applied to the skin, it exerts some antimicrobial and anti-inflammatory action, accompanied by a reduction in the severity of pain and itching.

The irritant (distracting) effect helps to eliminate pain sensations.

The local action is accompanied by vasoconstriction, a sensation of cold, turning into a sensation of slight burning and tingling.

Cutaneovisceral effects (the reflex arc does not involve the brain) improve tissue trophism (according to the zones of innervation).

Indications

• Infectious and inflammatory diseases of the upper respiratory tract (rhinitis, pharyngitis, laryngitis, tracheitis).

ICD codes

Dosage Regimen

Apply topically only. Avoid contact with eyes and mucous membranes.

For steam inhalations in respiratory tract diseases, use 15-20 drops per 200 ml of hot water. Inhale the vapors for 5-10 minutes, 2-3 times daily.

For intranasal application in rhinitis, apply 5-10 drops into each nasal passage. Use 2-3 times a day.

For topical application on skin, apply a small amount to the affected area and rub in gently. Use 2-3 times daily.

Do not apply to damaged skin or open wounds. The maximum duration of continuous use is 5-7 days.

Discontinue use if skin irritation or allergic reactions occur. Do not use in children under 3 years of age due to risk of reflex respiratory depression.

Adverse Reactions

Allergic reactions, contact dermatitis; with intranasal application in children – reflex respiratory depression (up to apnea) and collapse.

Contraindications

• Children under 3 years of age;
• Bronchial asthma;
• Individual hypersensitivity to the drug components.

Use in Pregnancy and Lactation

The use of the drug during pregnancy and breastfeeding is contraindicated (due to insufficient clinical data).

Pediatric Use

Contraindicated in children under 3 years of age.

Special Precautions

Effect on the ability to drive vehicles and machinery

The use of the drug does not affect the performance of potentially hazardous activities requiring increased attention and rapid reactions (driving vehicles, working with moving mechanisms).

Overdose

Overdose may lead to an increase in side effects.

Treatment symptomatic.

Drug Interactions

Not described.

Storage Conditions

In a place protected from light at a temperature not exceeding 15°C (59°F). Keep out of reach of children.

Shelf Life

Shelf life – 4 years.

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.