Boots Bite and Sting Relief Hydrocortisone Cream

1. Name Of The Medicinal Product

Boots Bite and Sting Relief 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

Insect bite and sting reactions

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 2-3 days. Do not use in pregnancy without medical advice or in children under 10.

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, athlete's foot, scabies or infected bites or stings.

4.4 Special Warnings And Precautions For Use

The product labelling shall 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, athlete's foot, scabies or infected bites or stings. Do not use for other bites or stings or for other skin conditions.

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

Treatment with hydrocortisone is usually well tolerated but treatment should be stopped if symptoms of hypersensitivity occur.

4.9 Overdose

No special precautions or antidotes are likely to be needed.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Hydrocortisone is a corticosteroid 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

Do not store above 25°C.

6.5 Nature And Contents Of Container

Internally lacquered collapsible aluminium membrane-sealed tube with a polypropylene cap. Pack size is 10g.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

The Boots Company PLC

1 Thane Road West

Nottingham

NG2 3AA

8. Marketing Authorisation Number(S)

PL 00014/0658