Composition:

Each 100g contains 10g Crotamiton and 0.25g Hydrocortisone.

Excipients: Lanette 18, lanette O, cutina, eumulgin B1, vasline, propylene glycol, methyl paraben, propyl paraben.

Mechanism of action:

CROTAMITON PLUS combines the antipruritic action of crotamiton with the anti-inflammatory and anti-allergic properties of hydrocortisone.

Indications:

CROTAMITON PLUS is indicated for the relief of inflammation and pruritus associated with:

• Irritant contact dermatitis
• Allergic contact dermatitis
• Insect bite reactions
• Mild to moderate eczema

Contraindications:

Hypersensitivity to the active substances or to any of the excipients, bacterial, viral or fungal infections of the skin. Acute exudative dermatoses. Application to ulcerated areas.

Use on the eyes/face, ano-genital region, broken or infected skin including cold sores, acne and athlete’s foot.

Precautions:

• Do not use in children under 10 years of age except under medical supervision.
• Occlusive dressing should not be used.
• CROTAMITON PLUS should not be used in buccal mucosa or other mucous membranes or in or around the eyes. In case of accidental contact with the eyes, or mucosa rinse thoroughly with running water.
• CROTAMITON PLUS should not be applied in the presence of exudative wounds, broken skin, or very inflamed skin.
• CROTAMITON PLUS contains propylene glycol which may cause skin irritation, stearyl alcohol which may cause local skin reactions, propyl hydroxybenzoate which may cause allergic reactions.

Side effects:

Occasionally at the site of application signs of irritation such as a burning sensation, itching, contact dermatitis/contact allergy may occur. Treatment should be discontinued if patients experience severe irritation or sensitisation.

Drug interactions: None known

Use in pregnancy and lactation:

It is not recommended during pregnancy, especially in the first three months.

It should not be used whilst breastfeeding unless under medical supervision.

Dosage & Method of administration:

For cutaneous use.

Adults and children over 10 years of age:

Apply sparingly over the affected area twice a day for a maximum period of 1 week. Occlusive dressings should not be used.

Do not use in children under 10 without medical advice.

CROTAMITON PLUS is indicated for external use only.

Overdosage:

CROTAMITON PLUS is for application to the skin only. If accidental ingestion of large quantities occurs, there is no specific antidote and general measures to eliminate the drug and reduce its absorption should be undertaken. Symptomatic treatment should be administered as appropriate.

Storage conditions: Store at temperature below 25°c.

Packaging: A metal tube contains 20g or 40g of CROTAMITON PLUS cream.