Reckitt Benckiser Ireland Limited

Hc45 Hydrocortisone Acetate Cream

(Hydrocortisone acetate 1% w/w)

Hydrocortisone acetate 1% w/w

Excipients:

Cetostearyl alcohol 7.2% w/w

For full list of excipients, see section 6.1.

Cream.

White, odourless or almost odourless cream

Allergic contact dermatitis

Irritant contact dermatitis

Insect bite reactions

Mild to moderate eczema

Adults and children over 10 years: Apply sparingly to a small area, once or twice a day, for a maximum of 7 days.

Do not use in pregnancy or in children under 10 without medical advice.

For topical administration.

Use in the presence of untreated infections of bacterial, viral, tuberculous or fungal origin.

Do not use on the eyes or face, the ano-genital area or on broken or infected skin, including impetigo, cold sores, acne or athlete's foot.

Use in acne rosacea or in perioral dermatoses.

Do not use on the eyes or face, the ano-genital area or on broken or infected skin, including impetigo, cold sores, acne or athlete's foot.

Do not use in pregnancy or in children under 10 without medical advice. If the condition does not improve, consult the doctor.

Continuous application without interruption will result in local atrophy of the skin, striae and superficial vascular dilatation, particularly of the face.

Prolonged use of uninterrupted occlusion or use with extensive occlusive dressings may suppress adrenocortical function.

This product contains ceteostearly alcohol which my cause local skin reactions (e.g. contact dermatitis).

None known.

Should not be used in pregnancy unless considered essential by the physician.

None known.

None known during the recommended period of treatment.

No special antidotes are likely to be required.

Hydrocortisone is a corticosteroid which has anti-inflammatory activity.

Hydrocortisone is a corticosteroid which has anti-inflammatory activity which is thought to result, at least in part from binding with a steroid receptor.

Hydrocortisone decreases inflammation by stabilising cell membranes, preventing the release of destructive enzymes, antagonising histamine and the release of kinins, inhibiting accumulation of macrophages and reducing capillary wall permeability and oedema formation.

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 layers and can be increased by inflammation or diseases of the epidermal barrier.

Hydrocortisone is absorbed to a greater degree from scrotum, axilla, eyelid, face and scalp than from the forearm, knee, palm and sole.

Liquid Paraffin

Cetomacrogol emulsifying wax (includes cetostearyl alcohol)

Phenoxyethanol

Purified water

Not applicable.

3 years

Do not store above 25°C.

Internally lacquered, membrane-sealed, collapsible aluminium tube with polypropylene or high density polythene cap containing 15g cream..

No special requirements

Reckitt Benckiser Ireland Ltd.,

7 Riverwalk,

Citywest Business Campus,

Dublin 24

PA 979/45/1

24^th September 1996 / 24^th September 2001

June 2011