Summary of Product Characteristics (SmPC) - Calamine cream Aqueous BP
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
Excipient(s) with specified warnings
Cetostearyl alcohol 4.0% w/w
For the full list of excipients, see section 6.1.
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 out of the sight and reach of children.
Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. Ingredients with specified warnings
This medicine contains Cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).
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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.
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
36 months unopened
Use within 12 months of first opening
6.4 Special precautions for storage
Do not store above 25ºC.
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 / 15/06/2001
10 DATE OF REVISION OF THE TEXT
04/09/2019