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CALAMINE CREAM AQUEOUS BP

Active substance(s): CALAMINE / ZINC OXIDE / CALAMINE / ZINC OXIDE / CALAMINE / ZINC OXIDE

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Aqueous Calamine Cream BP

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Calamine 4.0% w/w and Zinc Oxide 3.0% w/w

3

PHARMACEUTICAL FORM
Cream

4

CLINICAL PARTICULARS

4.1

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

4.2

Posology and method of administration
Topical application.
Adults, elderly and children: apply liberally to dry, clean skin as required.

4.3

Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in
section 6.1.

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.

4.5

Interaction with other medicinal products and other forms of interaction
May mask x-ray pictures under certain circumstances.

4.6

Fertility, 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.

4.7

Effects on ability to drive and use machines
None known

4.8

Undesirable effects
Occasional hypersensitivity or irritant reactions
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Not applicable

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Both Zinc Oxide and Calamine exhibit a mild astringent action when applied
to the skin.

5.2

Pharmacokinetic properties
None stated.

5.3

Preclinical safety data
None

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Liquid paraffin, glyceryl monostearate, macrogol cetostearyl ether 22,
cetostearyl alcohol, phenoxyethanol, purified water

6.2

Incompatibilities
None known

6.3

Shelf life
24 months unopened

6.4

Special precautions for storage
Do not store above 25ÂșC.
Do not allow to freeze.

6.5

Nature and contents of container
100g: White polyethylene/Aluminium/co-polymer MDPE laminated plastic
tube, with polypropylene cap.

6.6

Special precautions for disposal
None

7

MARKETING AUTHORISATION HOLDER
Thornton & Ross Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH

8

MARKETING AUTHORISATION NUMBER(S)
PL 00240/6276R

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
15/06/1988

10

/

15/06/2001

DATE OF REVISION OF THE TEXT
15/03/2017

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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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