Summary of Product Characteristics Updated 06-Sep-2019 | Thornton & Ross Ltd
Aqueous Calamine Cream BP
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.
Cream
For relief of the symptoms of mild sunburn and other minor skin conditions.
Topical application.
Adults, elderly and children: apply liberally to dry, clean skin as required.
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
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).
May mask x-ray pictures under certain circumstances.
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.
None known
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.
Not applicable
Both Zinc Oxide and Calamine exhibit a mild astringent action when applied to the skin.
None stated.
None
Liquid paraffin, glyceryl monostearate, macrogol cetostearyl ether 22, cetostearyl alcohol, phenoxyethanol, purified water
None known
36 months unopened
Use within 12 months of first opening
Do not store above 25° C.
Do not allow to freeze.
100g: White polyethylene/Aluminium/co-polymer MDPE laminated plastic tube, with polypropylene cap.
None
Thornton & Ross Ltd.
Linthwaite Laboratories
Huddersfield
HD7 5QH
PL 00240/6276R
15/06/1988 / 15/06/2001
04/09/2019
Linthwaite, Huddersfield, West Yorks, HD7 5QH
+44(0)1484 848200
+44 (0) 1484 848164