Boots Derma Care Hydrocortisone 1% Ointment

Ointment

POM: For the treatment of mild to moderate inflammatory skin disorders such as eczema, including atopic, infantile, discoid and stasis eczema; seborrhoeic dermatitis, intertrigo, otitis externa, contact dermatitis, neurodermatitis flexural psoriasis and lichen simplex.

P: For the relief of irritant contact dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema.

POM: For adults and children: Apply sparingly twice a day.

P: For adults, the elderly and children over 10 years of age: Apply sparingly to a small area, once or twice a day, for a maximum of 7 days.

Children under 10 years of age: Not recommended except under medical supervision.

For topical application.

POM: Should not be used if allergic to any of the ingredients or on untreated, infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.

P: The product should not be used if allergic to any of the ingredients or on the eyes or face, the ano-genital area or on broken or infected skin including impetigo, cold sores, acne or athlete's foot.

POM: Avoid prolonged, continuous use, particularly in children and especially on the face, as adrenal suppression may occur.

P: Medical advice should be sought if the condition does not improve.

P and POM: No clinically significant interactions known.

POM: There is inadequate evidence of safety in human pregnancy. Topical application of corticosteroids to pregnant animals can cause abnormalities of foetal development. There may, therefore, be a very small risk of such effects in the human foetus.

P: This product should not be used in pregnancy without medical advice. There is no information about effects during lactation.

P and POM: No adverse effects known.

POM: The product is usually well tolerated, but if hypersensitivity occurs use of the product should be discontinued.

Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and the nappy area and where occlusive dressings are used. Sufficient systemic absorption may occur at these sites to produce features of suppression of the HPA (hypothalamo-pituitary-adrenal) axis after prolonged treatment.

P: Hydrocortisone Ointment 1% is usually well tolerated but if hypersensitivity occurs discontinue use.

POM: Acute overdosage is very unlikely to occur. In the case of chronic overdosage or misuse the features of hypercorticism may appear and in this situation, topical steroids should be discontinued.

P: No special precautions or antidotes are likely to be needed.

Hydrocortisone is a corticosteroid which has antiinflammatory activity.

Following topical application to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation. Absorption may be markedly increased when the skin has lost its keratin layer and can be increased by inflammation or diseases of the epidermal barrier. Hydrocortisone is absorbed to a greater degree from the scrotum, axilla, eyelid, face and scalp than from the forearm, knee, elbow, palm and sole.

There are no preclinical data of relevance to the prescriber which are additional to that already included.

White soft paraffin.

Not applicable.

36 months.

Do not store above 25°C.

P: 15 gram internally lacquered, collapsible, aluminium tubes with polypropylene caps. The tubes are packed into cartons.

POM: 15, 30 and 50 gram internally lacquered, collapsible, aluminium tubes with polypropylene caps. The tubes are packed into cartons.

Not applicable.

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

Trading as: BCM

PL 00014/0364.

14 April 1987 / 17 June 1997

May 2010