Calamine And Glycerin Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1
2
3
4
4.1
4.2.
4.3.
4.4.
NAME OF THE MEDICINAL PRODUCT
Calamine and Glycerin Cream
QUALITATIVE AND QUANTITATIVE COMPOSITION
|
Active Ingredients |
%w/w |
|
Zinc Oxide Ph Eur |
5 |
|
Calamine BP |
15 |
|
Glycerin Ph Eur |
5 |
PHARMACEUTICAL FORM
Cream
CLINICAL PARTICULARS
Therapeutic indications
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.
Contra-indications
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.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant drug interactions known.
May mask x-ray pictures under certain circumstances.
4.6. 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.
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.
4.9. Overdose
Symptoms of overdosage include anorexia, nausea, vomiting, epigastric discomfort and diarrhoea. Treatment consists of symptomatic measures only.
PHARMACOLOGICAL PROPERTIES
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5.1 Pharmacodynamic properties
Calamine has a mild astringent action on the skin. Zinc oxide has mild astringent, soothing and protective qualities.
Glycerol has emollient properties.
5.2. Pharmacokinetic Properties
Not available.
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
Polawax A31 Paraffin light liquid Isopropyl myristate Polysorbate 80 Bentonite
Sodium citrate gran Water purified Liquefied phenol
6.2. Incompatibilities
None known.
6.3.
Shelf Life
36 months.
6.4. Special Precautions for Storage
None.
6.5 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.
6.6. Instruction for Use/Handling
None stated.
7. MARKETING AUTHORISATION HOLDER
The Boots Company PLC 1 Thane Road West Nottingham NG2 3AA
8. MARKETING AUTHORISATION NUMBER
PL 00014/5129R
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION
Date of First Authorisation: 9 November 1984 Last Renewal: 22 December 1994
10 DATE OF REVISION OF THE TEXT
January 2015