EURAX Cream Ref.[27512] Active ingredients: Crotamiton

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Thornton & Ross Ltd., Linthwaite, Huddersfield, HD7 5QH, UK

4.1. Therapeutic indications

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

The treatment of scabies.

4.2. Posology and method of administration

Pruritus

Adults (including the elderly)

Apply to the affected area 2-3 times daily. Eurax/Boots Dermacare Itch Relief Cream will provide relief from irritation for 6 to10 hours after each application. There are no special dosage recommendations in the elderly.

Paediatric population

Eurax/ Boots Dermacare Itch Relief Cream can be used in children. However for children under three years of age, usage should only be used 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 Eurax/ Boots Dermacare Itch Relief 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 (eg interdigital spaces, wrists, axillae and genitalia). Areas where there is pus formation should be covered with a dressing impregnated with Eurax/ Boots Dermacare Itch Relief 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

Eurax/Boots Dermacare Itch Relief Cream can be used in children. For children under three years of age consult a doctor before use and do not apply more than once a day.

Method of administration

For cutaneous use.

4.9. Overdose

In cases of accidental ingestion, acute intoxication symptoms may be observed such as nausea, vomiting and irritation of the buccal, oesophageal and gastric mucosa. Rare cases of loss of consciousness and seizure were reported. General measures to eliminate the drug and reduce its absorption should be undertaken.

Symptomatic treatment should be administered as appropriate. Moreover although very rare, risk of methaemoglobinaemia exists in case of accidental ingestion as well as in case of excessive cutaneous absorption. The symptoms usually disappear following the discontinuation of the drug, but in severe cases treatment with methylene blue may be considered.

6.3. Shelf life

30 months.

6.4. Special precautions for storage

Do not store above 25°C.

6.5. Nature and contents of container

Internally lacquered aluminium tube with an inner coating made of epoxy-phenol resin lacquer closed with a polyethylene screw cap, in a cardboard carton.

Pack sizes: 20, 30 and 100g

6.6. Special precautions for disposal and other handling

None.

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