CROTAMITON

Excipients: Glyceryl Monostearate, Cetostearyl Alcohol, Emulgin B2, Vaseline, Methyl Paraben Sodium, Propyl Paraben Sodium, Deionized water.

PROPERTIES:

Crotamiton has a symptomatic action on pruritus and is an acaricide. As an acaricide agent, crotamiton is effective on the motor system of the mites by inducing irreversible cessation of spontaneous movements.

The Cream will provide relief from irritation for 6 to 10 hours after each application.

PHARMACOKINETIC PROPERTIES:

Crotamiton 10% Cream penetrates rapidly into human skin. Low but measurable concentrations of crotamiton are found in plasma, with a maximum level after 4-10 hours, declining rapidly thereafter.

INDICATIONS:

-For the relief of itching and skin irritation caused by sunburn, dry eczema, itchy dermatitis, allergic rashes, hives, nettle rash, chickenpox, insect bites and stings, heat rashes and personal itching.

-The treatment of scabies.

CONTRAINDICATIONS:

-Acute exudative dermatoses.

-Hypersensitivity to the active substance or to any of the excipients

PRECAUTIONS:

-For external use only.

-CROTAMITON cream can be used for children. However, for children under three years of age; usage should only be under medical supervision.

– CROTAMITON cream should not be used in buccal mucosa and in or around the eyes since contact with the eyelids may give rise to conjunctival inflammation.

-In case of accidental contact with the eyes, or buccal mucosa rinse thoroughly with running water.

-Should not be applied in the presence of exudative wounds, acute eczema, broken skin, or very inflamed skin.

-In the presence of eczematous scabies, eczema should be treated before the scabies.

– CROTAMITON cream contains stearyl alcohol which may cause local skin reactions (e.g. contact dermatitis) and methyl hydroxybenzoate which may cause allergic reactions (possibly delayed).

Pregnancy:

CROTAMITON cream is not recommended during pregnancy, especially in the first three months. Breastfeeding:

Mothers should not use CROTAMITON cream whilst breastfeeding unless directed by a physician. If the cream is used during breastfeeding it should not be applied to the nipple area

SIDE EFFECTS:

Skin and subcutaneous tissue disorders:

Uncommon: pruritus

Rare: contact dermatitis, hypersensitivity (including/like rash, eczema, erythema, skin irritation, angioedema) Treatment should be discontinued if sever irritation occurs.

DOSES:

Pruritus:

Adults (including the elderly):

Apply to the affected area 2 to 3 times daily.

CROTAMITON cream will provide relief from irritation for 6 to 10 hours after each application.

There are no special dosage recommendations in the elderly.

Paediatric population:

CROTAMITON cream can be used in children. However for children under three years of age usage should only be under medical supervision and it should not be applied more than once a day.

Scabies:

Adults (including the elderly):

After the patient has taken a warm bath, the skin should be well dried and CROTAMITON cream rubbed into the entire body surface (excluding the face and scalp) until no traces of the preparation remain visible on the surface. The application should be repeated once daily, preferably in the evening, for a total of 3-5 days.

Depending on the response, special attention should be paid to sites that are particularly susceptible to infestation by the mites (e.g. interdigital spaces, wrists, axillae and genitalia).

Areas where there is pus formation should be covered with a dressing impregnated with CROTAMITON cream. While the treatment is in progress the patient may take a bath shortly before the next application.

After completion of the treatment, a cleansing bath should be taken followed by a change of bed linen and underclothing.

There are no special dosage recommendations in the elderly.

Paediatric population:

CROTAMITON cream can be used in children. However, for children under three years of age usage should only be under medical supervision and it should not be applied more than once a day.

Method of administration: For cutaneous use.

STORAGE CONDITIONS:

Store at temperature below 25 °C.

Protect from light and moisture.

PACKAGING:

Aluminum tube contains 20 gr. CROTAMITON cream/Carton box.

Aluminum tube contains 40 gr. CROTAMITON cream/Carton box.