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BOOTS COMPANY PLC
1 Thane Road West, Beeston, Nottingham, NG2 3AA Telephone: +44 (0)1159 595 306 Fax: +44 (0)1159 592 565 Need to contact this company?

Summary of Product Characteristics last updated on the eMC: 09/12/2003

SPC	Boots Cradle Cap Cream from Birth

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT

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1. NAME OF THE MEDICINAL PRODUCT

Childrens Cradle Cap Cream or Infant Cradle Cap Cream or Boots Cradle Cap Cream from Birth.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredients	%w/w
Anhydrous lanolin	1.0
Almond oil BP'88	5.0

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3. PHARMACEUTICAL FORM

Cream

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For the treatment of cradle cap.

For topical application to the scalp.

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4.2 Posology and method of administration

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

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4.3 Contraindications

Hypersensitivity to any of the ingredients.

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4.4 Special warnings and precautions for use

For external use only.

Keep all medicines out of the reach of children.

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4.5 Interaction with other medicinal products and other forms of interaction

There are no clinically significant interactions known.

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4.6 Pregnancy and lactation

The safety of Children's Cradle Cap Cream during pregnancy and lactation has not

been established but is not considered to constitute a hazard during these periods.

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4.7 Effects on ability to drive and use machines

No adverse effects known.

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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.

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4.9 Overdose

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

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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

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

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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.

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5.3 Preclinical safety data

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

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6. PHARMACEUTICAL PARTICULARS

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6.1 List of excipients

White soft paraffin

Cetomacrogol 1000

Arlacel 83

Cetyl alcohol

Benzyl alcohol

Anhydrous citric acid

Sodium citrate

Purified water

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6.2 Incompatibilities

None stated

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6.3 Shelf life

36 months

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6.4 Special precautions for storage

None stated.

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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.

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6.6 Special precautions for disposal and other handling

None stated.

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7. MARKETING AUTHORISATION HOLDER

The Boots Company PLC

1 Thane Road West

Nottingham NG2 3AA

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8. MARKETING AUTHORISATION NUMBER(S)

PL 0014/0368