Calamine and Glycerin cream

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Calamine; Glycerol; Zinc oxide

Available from:

The Boots Company Plc

ATC code:

D02AB

INN (International Name):

Calamine; Glycerol; Zinc oxide

Dosage:

150mg/1gram ; 50mg/1gram ; 50mg/1gram

Pharmaceutical form:

Cutaneous cream

Administration route:

Cutaneous

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 13030000; GTIN: 5000167084986

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Calamine and Glycerin Cream
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredients
%w/w
Zinc Oxide Ph Eur
5
Calamine BP
15
Glycerin Ph Eur
5
3
PHARMACEUTICAL FORM
Cream
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the relief of sunburn. windburn, rough, dry hands, chapped and
tender skin
and for the relief of skin irritation.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
For topical application
Adults and Children:
To be applied gently to the affected parts when required.
4.3.
CONTRA-INDICATIONS
Hypersensitivity to any of the ingredients.
4.4.
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.
5
PHARMACOLOGICAL PROPERTIES
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 avai