This information is intended for use by health professionals
1. Name of the medicinal product
Calamine Lotion BP
2. Qualitative and quantitative composition
|Active ingredients||% w/v|
|Zinc Oxide||Ph Eur||5|
3. Pharmaceutical form
4. Clinical particulars
4.1 Therapeutic indications
For the relief of minor skin rashes and irritation.
4.2 Posology and method of administration
Adults, children and elderlyTo be applied when required to the affected area. For topical application.
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Shake the bottle.For external use only.Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.May mask x-ray pictures under certain circumstances.
4.6 Pregnancy and lactation
The safety of Calamine Lotion during pregnancy and lactation has not been established but use during these periods is not considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
No adverse effects 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.
If ingested symptoms of overdosage include anorexia, nausea, vomiting, epigastric discomfort and diarrhoea. Treatment consists of symptomatic measures only.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Calamine has a mild astringent action on the skin.
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
6. Pharmaceutical particulars
6.1 List of excipients
BentoniteGlycerolSodium CitratePhenolWater Purified
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
A white flint glass bottle with an unlined polypropylene cap. An amber glass bottle with vinyl seal faced compocork in thermoset plastic cap. Alternative cap: Aluminium roll-on pilfer-proof cap with a flowed in liner or a triseal (LDPE/EPE/LDPE) liner. Pack sizes: 200, 2000 millilitres
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
The Boots Company PLC1 Thane Road WestNottingham NG2 3AATrading as: BCM
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
|Date of First Authorisation:||31 October 1984|
|Date of Last Renewal:||23 January 1996|
10. Date of revision of the text
16 December 2014