Hc45 Hydrocortisone Cream (Reckitt Benckiser Healthcare (UK) Ltd)

1. Name Of The Medicinal Product

Hc45 Hydrocortisone Cream

2. Qualitative And Quantitative Composition

Hydrocortisone Acetate BP 1.0% w/w

3. Pharmaceutical Form

A smooth, white cream.

4. Clinical Particulars

4.1 Therapeutic Indications

Irritant contact dermatitis, allergic contact dermatitis, insect bite reactions, mild to moderate eczema.

4.2 Posology And Method Of Administration

For topical administration.

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.

4.3 Contraindications

The product should not be used on the eyes or face, the ano-genital area or on broken or infected skin including impetigo, cold sores, acne or athlete's foot.

4.4 Special Warnings And Precautions For Use

The product labelling will include the following statements:-

If the condition does not improve consult your doctor. Do not use on the eyes or face, anal or genital areas or on broken skin or infected skin, e.g. impetigo, cold sores, acne or athlete's foot.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

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

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

None known.

4.9 Overdose

No special precautions or antidotes are likely to be needed.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Hydrocortisone is a corticosteriod which has anti-inflammatory activity.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

There are no preclinical safety data of relevance to the consumer.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White soft paraffin

Liquid paraffin

Phenoxyethanol

Purified water

Cetomacrogol emulsifying wax

6.2 Incompatibilities

None known.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

Internally lacquered collapsible aluminium membrane-sealed tube with a polypropylene cap. Pack size is 15g.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Reckitt Benckiser Healthcare (UK) Ltd

Slough

SL1 4AQ

8. Marketing Authorisation Number(S)

PL 00063/0647

9. Date Of First Authorisation/Renewal Of The Authorisation

7 November 1986 / 12 November 1998

10. Date Of Revision Of The Text

11/05/2011