CALAMINE AND GLYCERIN CREAM
Active substance(s): CALAMINE / GLYCEROL / ZINC OXIDE
NAME OF THE MEDICINAL PRODUCT
Calamine and Glycerin Cream
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinc Oxide Ph Eur
Glycerin Ph Eur
For the relief of sunburn. windburn, rough, dry hands, chapped and tender skin
and for the relief of skin irritation.
Posology and Method of Administration
For topical application
Adults and Children:
To be applied gently to the affected parts when required.
Hypersensitivity to any of the ingredients.
Special Warnings and Precautions for Use
For external use only.
Keep all medicines out of the reach of children.
Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
May mask x-ray pictures under certain circumstances.
Pregnancy and Lactation
The safety of Calamine and Glycerin Cream during pregnancy and lactation
has not been established but its use during these periods is not considered to
constitute a hazard.
Effects on Ability to Drive and Use Machines
No adverse effects 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
Symptoms of overdosage include anorexia, nausea, vomiting, epigastric
discomfort and diarrhoea. Treatment consists of symptomatic measures only.
Calamine has a mild astringent action on the skin. Zinc oxide has mild
astringent, soothing and protective qualities.
Glycerol has emollient properties.
Preclinical Safety Data
There are no preclinical data of relevance to the prescriber which are
additional to that already included.
List of Excipients
Paraffin light liquid
Sodium citrate gran
Special Precautions for Storage
Nature and contents of container
An internally lacquered collapsible tube with latex welt having a
polypropylene or polythene cap, in a cardboard carton.
Pack size: 35 gm.
Instruction for Use/Handling
MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF
Date of First Authorisation: 9 November 1984
Last Renewal: 22 December 1994
DATE OF REVISION OF THE TEXT
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.