Galderma (U.K) Ltd

Calmurid HC 10%/ 5%/ 1% Cream

Urea 10.0% w/w

Lactic Acid 5.0% w/w

Hydrocortisone 1.0% w/w

For a full list of excipients, see section 6.1

Cream

A smooth white, oil-in-water cream.

In the management of dermatoses characterised by hyperkeratosis and inflammation.

For external use only.

Apply twice daily to the affected areas or as directed by the physician.

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

2. Use in acne rosacea or in perioral dermatoses.

3. Use in plaque psoriasis.

1. Continuous treatment longer than three weeks should be avoided in patients under the age of three years because of the possibility of adrenocortical suppression and growth retardation.

2. Prolonged use of uninterrupted occlusion (including napkins) or use with extensive occlusive dressings may suppress adrenocortical function.

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

4. Prolonged use in the management of acne vulgaris should be avoided.

5. Use in psoriasis may lead to generalisation, excessive systemic absorption and rebound relapse on cessation of use.

None known.

Animal studies have shown teratogenic effects. To date similar effects have not been shown to occur in man. This product should not be used in pregnancy or lactation unless considered essential by the physician.

None known.

If applied to open wounds or mucous membranes the hypertonic and acidic nature of the preparation may produce smarting. In such cases wash off with water. Where smarting is a barrier to therapy, dilute with an equal quantity of aqueous cream: after a week of treatment with this material, the normal strength should be tolerated.

The barrier function in the skin to steroid uptake, the low toxicity of hydrocortisone and the natural mechanism for its rapid inactivation make overdose unlikely.

A combination of a synthetic form of a naturally occurring corticosteriod, absorbable in part after topical application, with a keratolytic.

Not applicable.

Urea, lactic acid and hydrocortisone are long established materials whose pre-clinical profile is known.

Glyceryl monostearate

Betaine monohydrate

Diethanolamine cetylphosphate

Hard fat

Cholesterol

Sodium chloride

Purified water

Do not mix with other preparations, as the effect on the stability of each is unknown. Do not pack in alloy containers as they may react with the lactic acid.

2 years.

Do not store above 25°C.

Polypropylene tubes.

Pack sizes: 30g, 50g & 100 g.

Not all pack sizes may be marketed.

No special requirements

Galderma (UK) Limited

Meridien House

69-71 Clarendon Road

Watford

Herts

WD17 1DS

UK

PA 590/9/1

Date of first authorisation: 1^st April 1978

Date of last renewal: 20^th April 2009

April 2010