Calamine Lotion BP

国家: 马耳他

语言: 英文

来源: Medicines Authority

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下载 资料单张 (PIL)
03-06-2024
下载 产品特点 (SPC)
03-06-2024

有效成分:

CALAMINE, ZINC OXIDE

可用日期:

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

ATC代码:

D02AX

INN(国际名称):

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

药物剂型:

CUTANEOUS SUSPENSION

组成:

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

处方类型:

OTC

治疗领域:

EMOLLIENTS AND PROTECTIVES

授权状态:

Withdrawn

授权日期:

2006-05-31

产品特点

                                 
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
                                
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