Calamine Lotion BP

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

CALAMINE, ZINC OXIDE

Available from:

Bell Sons & Co. (Druggists) Limited Gifford House, Slaidburn Crescent, Southport, Mersyside PR 9 9AL, United Kingdom

ATC code:

D02AX

INN (International Name):

CALAMINE 100 % (W/V) ZINC OXIDE 15 % (W/V)

Pharmaceutical form:

CUTANEOUS SUSPENSION

Composition:

CALAMINE 100 % (W/V) ZINC OXIDE 15 % (W/V)

Prescription type:

OTC

Therapeutic area:

EMOLLIENTS AND PROTECTIVES

Authorization status:

Withdrawn

Authorization date:

2006-05-31

Summary of Product characteristics

 
Page 1 of 3 

SUMMARY OF PRODUCT CHARACTERISTICS 

PRODUCT SUMMARY 

1. 
NAME OF THE MEDICINAL PRODUCT 

 Calamine 
Lotion 
BP 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Calamine BP   
15% w/v 

Zinc Oxide BP  
5% w/v 

3. PHARMACEUTICAL 
FORM 

 Cutaneous 
suspension 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Use as a mild astringent, cooling
lotion for minor skin irritations and sunburn. Administered by 
application to skin. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

For children, adults and the elderly apply with cotton wool to the
affected area as required.  

4.3 CONTRA-INDICATIONS 

Known hypersensitivity to any of the ingredients 

4.4 
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE 

Shake bottle well. 

For external use only. 

Do not use on broken skin.  

4.5 
INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS
OF INTERACTION 
 None 
known 

4.6 PREGNANCY 
AND 
LACTATION 

Acceptable for use in pregnancy and lactation.  

Page 2 of 3 
4.7 
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 

 None 

4.8 UNDESIRABLE 
EFFECTS 

 None 
known 

4.9 OVERDOSE 

If accidentally ingested treat symptomatically. 

5. PHARMACOLOGICAL 
PROPERTIES 
5.1 PHARMACODYNAMIC 
PROPERTIES 

Calamine has a mild astringent on the skin and is used to
relieve the discomfort of dermatitis. 

Calamine lotion cools the skin by evaporation and is useful for
allaying the pain and swelling of 
sunburn. 

Zinc oxide is applied externally as a mild astringent for the skin
and protective application in 
eczema and as a protective for slight excoriations. 

5.2 PHARMACOKINETIC 
PROPERTIES 

 Not 
applicable 

5.3 
PRECLINICAL SAFETY DATA 

 None 
available 

6. PHARMACEUTICAL 
PARTICULARS 

6.1 
LIST OF EXCIPIENTS 
 Bentonite 
BP 

Sod