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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

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 04/05/2011

SPC	Boots Aqueous Cream B.P.

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

Aqueous Cream B.P.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient

% w/w

White Soft Paraffin BP

Liquid Paraffin BP

15.0

6.0

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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 symptomatic relief of dry skin disorders.

For topical application to the skin.

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4.2 Posology and method of administration

Adults, children and elderly:

To be applied to the skin as required.

May also be used as a soap substitute.

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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

No clinically significant drug interactions known.

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4.6 Pregnancy and lactation

The safety of aqueous 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

Occasional hypersensitivity reactions.

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4.9 Overdose

Symptoms of accidental oral ingestion may include gastrointestinal symptoms, particularly diarrhoea. Treatment need only be symptomatic.

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5. PHARMACOLOGICAL PROPERTIES

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