Vicks Active Balm with menthol and eucalipt (Ointment) Instructions for Use

Marketing Authorization Holder

Procter & Gamble Distributor Company LLC (Russia)

Manufactured By

Procter & Gamble Manufacturing, GmbH (Germany)

ATC Code

R05X (Other remedies for the treatment of colds)

Dosage Form

Vicks Active Balm with menthol and eucalipt

Ointment for external use: 25 g, 50 g or 100 g jars

Dosage Form, Packaging, and Composition

Ointment for external use from white to yellowish-white in color, soft, homogeneous, with a characteristic odor.

Excipients: thymol – 0.25 g, cedarwood oil – 0.45 g, white soft paraffin – up to 100 g.

25 g – polypropylene jars (1) – cardboard packs.
50 g – polypropylene jars (1) – cardboard packs.
100 g – polypropylene jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with counterirritant action, used externally for colds and cough

Pharmacotherapeutic Group

Local irritant of natural origin

Pharmacological Action

A combined drug, the action of which is due to the components that make up its composition. It has a local irritant, anti-inflammatory and antiseptic effect.

A reduction in the degree of nasal congestion after a single application of the drug is observed for up to 8 hours.

Pharmacokinetics

No data available.

Indications

As part of the complex therapy of inflammatory diseases of the respiratory tract, accompanied by

• Runny nose;
• Feeling of nasal congestion;
• Cough and sore throat.

ICD codes

Dosage Regimen

The drug is intended for external use (rubbing) in adults and children over 2 years of age.

The ointment should be rubbed in with gentle movements 2-4 times/day on the skin of the chest for runny nose and nasal congestion; on the skin of the neck – for cough and sore throat; on the skin of the back – for cough.

The duration of treatment is on average up to 5 days.

Adverse Reactions

Possible allergic reactions, laryngospasm, bronchospasm, skin irritation at the site of application of the drug, lacrimation.

Contraindications

• Tendency to laryngo- and bronchospasm;
• Bronchial asthma;
• Whooping cough;
• False croup (acute stenosing laryngotracheitis);
• Cough caused by accumulation of sputum (mucus);
• Prolonged or chronic cough caused by smoking or emphysema;
• Skin lesions and skin diseases in the area of the intended application of the drug;
• Children under 2 years of age;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Due to the lack of experience of use in pregnant and breastfeeding women, the use of the drug in this group is not recommended.

Pediatric Use

Contraindicated in children under 2 years of age.

Special Precautions

Do not swallow. Do not apply the drug to the skin in the area of the nose and/or face. Avoid getting the drug into the eyes, on the mucous membranes of the nose, and oral cavity.

If the ointment accidentally gets into the eyes and on the mucous membranes, it is recommended to rinse thoroughly with water.

Never heat the drug or use it in a heated state.

After rubbing, clothing covering the area of application of the drug should not be too tight.

If the condition does not improve within 5 days or becomes worse, the patient should consult a doctor.

Effect on the ability to drive vehicles and machinery

The use of the drug does not have a negative effect on the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (including driving a car and other vehicles, working with moving mechanisms).

Overdose

Symptoms: skin irritation at the sites of application of the drug, bronchospasm, laryngospasm.

Treatment: excess amount of ointment can be removed using a gauze or paper napkin moistened with vegetable oil.

In case of broncho- or laryngospasm, the patient should immediately consult a doctor.

Drug Interactions

Not studied.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 4 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.