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Thornton & Ross Ltd

Telephone: +44 (0)1484 842217
Fax: +44 (0)1484 847301
WWW: http://www.thorntonandross.com
Medical Information Direct Line: +44(0)1484 848 251

Medical Information e-mail: phv@thorntonross.co.uk
Customer Care direct line: +44(0)1484 842 217
Medical Information Fax: +44(0)1484 847 301

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: 10/11/2011

SPC	Aqueous Calamine Cream BP

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
11. DOSIMETRY
12 INSTRUCTIONS FOR PREPARATION OF RADIOPHARMACEUTICALS

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1. NAME OF THE MEDICINAL PRODUCT

Aqueous Calamine Cream BP.

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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Calamine BP 4.0% w/w and Zinc Oxide BP 3.0% w/w.

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3. PHARMACEUTICAL FORM

Cream.

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4. CLINICAL PARTICULARS

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4.1 Therapeutic indications

For relief of the symptoms of mild sunburn and other minor skin conditions.

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4.2 Posology and method of administration

Topical application.

Adults, elderly and children: apply liberally to dry, clean skin as required.

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4.3 Contraindications

Hypersensitivity to Phenoxyethanol or any other ingredient.

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4.4 Special warnings and precautions for use

For external use only.

Keep securely closed when not in use.

Keep all medicines away from children.

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4.5 Interaction with other medicinal products and other forms of interaction

May mask x-ray pictures under certain circumstances.

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4.6 Pregnancy and lactation

No information is available on the use of this product during pregnancy and lactation. However, it is unlikely that its use would cause any adverse effects.

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4.7 Effects on ability to drive and use machines

None known.

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4.8 Undesirable effects

None known.

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4.9 Overdose

Not applicable.

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5. PHARMACOLOGICAL PROPERTIES

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