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BOOTS CRADLE CAP CREAM

Active substance(s): ALMOND OIL / ANHYDROUS LANOLIN / ALMOND OIL / ANHYDROUS LANOLIN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Boots Cradle Cap Cream

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient Anhydrous lanolin Almond oil BP88 % w/w 1.0 5.0

3.

PHARMACEUTICAL FORM Cream

4. 4.1

CLINICAL PARTICULARS 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 special precautions for use

For external use only. Keep all medicines out of the reach of children.

4.5

Interactions with other medicinal products and other forms of interaction There are no clinically significant drug interactions known.

4.6

Pregnancy and lactation The safety of Childrens Cap Cream 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. 5.1

PHARMACOLOGICAL PROPERTIES 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. 6.1

PHARMACEUTICAL PARTICULARS 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

Instructions for use/handling None stated.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA

8.

MARKETING AUTHORISATION NUMBER PL 0014/0368

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION First Authorisation: 16 May 1988 Last Renewal: 19 May 1999

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DATE OF REVISION OF THE TEXT
30/11/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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