Drapolene (Cream) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Healthcare, JSC (Russia)

Manufactured By

GlaxoSmithKline Pharmaceuticals, S.A. (Poland)

ATC Code

D08AJ (Quaternary ammonium compounds)

Active Substances

Benzalkonium chloride (Rec.INN registered by WHO)

Cetrimide (Rec.INN registered by WHO)

Dosage Form

Drapolene

Cream for external use 0.1 mg+2 mg/1 g: tube 55 g

Dosage Form, Packaging, and Composition

Cream for external use homogeneous, pink in color.

Excipients : white soft paraffin – 100 mg, anhydrous lanolin – 20 mg, cetyl alcohol – 50 mg, polywax GP200 – 50 mg, chlorocresol – 1 mg, carmoisine (E122) – 0.02 mg, purified water – up to 1000 mg.

55 g – laminated tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Antiseptic for external use

Pharmacotherapeutic Group

Antiseptic and disinfectant

Pharmacological Action

A combined antiseptic for external use. The active components of the drug – Benzalkonium chloride and Cetrimide – are quaternary ammonium compounds.

It has antiseptic and disinfecting action.

The drug has antimicrobial activity against gram-positive bacteria, and to a lesser extent – against gram-negative bacteria. It is not active against acid-fast bacteria and bacterial spores.

Pharmacokinetics

Pharmacokinetic data are not available.

Indications

• Prevention and treatment of diaper dermatitis;
• As a first aid remedy for minor skin injuries (minor burns, cuts, scratches, and sunburns).

ICD codes

Dosage Regimen

The drug is intended for external use only.

Diaper rash ininfants from birth

Before using the drug, wash and dry the affected area.

For treatment, at the first signs of dermatitis (redness, chafing, or minor skin irritation), apply the cream 3 or more times a day, as needed, usually at every diaper change.

For prevention, apply to the skin covered by diapers, especially before bedtime, when the child may be in wet diapers for a long time.

Cuts, scratches, and sunburns

Apply the cream in a thin layer; if necessary, apply a gauze bandage.

Apply only to superficial and non-infected lesions.

Adverse Reactions

In case of hypersensitivity, allergic reactions may develop.

Contraindications

• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Data on the use of the drug during pregnancy and lactation are not available.

Pediatric Use

Use is possible according to the dosage regimen.

Special Precautions

Avoid contact of the drug with the eyes.

If the rash does not disappear within 48-72 hours, it is necessary to consult a doctor.

The cream should not be applied to infected skin with impaired integrity.

Overdose

Not known.

Drug Interactions

Soap and anionic surfactants reduce the effectiveness of the drug.

Storage Conditions

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

Shelf Life

The shelf life is 3 years. Do not use after the expiration date.

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.