BOOTS CRADLE CAP CREAM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Boots Cradle Cap Cream

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient                 % w/w

Anhydrous lanolin                 1.0

Almond oil BP’88                5.0

3. PHARMACEUTICAL FORM

Cream

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

For the treatment of cradle cap.

For topical application to the scalp.

4.2 Posology and method of administration

Apply to the affected area two or three times a day as required.

4.3 Contraindi­cations

Hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

For external use only.

Keep all medicines out of the reach of children.

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.

4.5 Interaction with other medicinal products and other forms of interaction There are no clinically significant interactions known.4.6 Fertility, pregnancy and lactation

The safety of this product during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.

4.7 Effects on ability to drive and use machines

No adverse effects known.

4.8 Undesirable effects

Adverse reactions are unlikely, but may occasionally cause an allergic skin reaction, in which case use of the product should be discontinued.

4.9 Overdose

Childrens Cradle Cap Cream has low toxicity. If accidental ingestion occurs, conservative treatment only is required.

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic Properties

Lanolin and almond oil help to moisturise the skin and prevent soreness.

5.2 Pharmacokinetic Properties

Lanolin is not by itself readily absorbed but when mixed with a suitable vegetable oil, in this case almond oil, it gives emollient creams which penetrate the skin.

5.3 Preclinical Safety Data

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

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

White soft paraffin

Cetomacrogol 1000

Arlacel 83

Cetyl alcohol

Benzyl alcohol

Anhydrous citric acid

Sodium citrate

Purified water

6.2 Incompatibilities

None stated

6.3 Shelf life

36 months

6.4 Special precautions for storage

None stated.

6.5 Nature and contents of container

An internally lacquered, collapsible aluminium tube with a memberane seal and either a polyethylene or polypropylene white wadless screw cap with a piercer device.

Pack sizes: 22gm, 25gm.

6.6 Special precautions for disposal None stated.

7 MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

8 MARKETING AUTHORISATION NUMBER(S)

PL00014/0368

9. DATE OF FIRST AUTHORISATION/RE­NEWAL OF THE

AUTHORISATION

First Authorisation: 16 May 1988

Last Renewal: 19 May 1999