CALAMINE Cutaneous Suspension
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
CALAMINE ZINC OXIDE
Available from:
Rowa Pharmaceuticals Limited
Pharmaceutical form:
Cutaneous Suspension
Authorization date:
1994-12-12
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calamine Lotion BP 15% w/v Cutaneous Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calamine 15% w/v
For excipients see 6.1.
3 PHARMACEUTICAL FORM
Cutaneous Suspension
A pale pink liquid with a faint smell of phenol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calamine Lotion is indicated for the symptomatic relief of skin irritation due to sunburn, heat rash and allergic
reactions.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
ROUTE OF ADMINISTRATION: cutaneous use
RECOMMENDED DOSAGE SCHEDULE:
Apply to the affected areas 3-4 times daily or as directed by
the physician.
4.3 CONTRAINDICATIONS
There are no contra-indications to the use of Calamine Lotion.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
If symptoms persist consult your doctor.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known.
4.6 PREGNANCY AND LACTATION
There is no known contra-indication to
the use of Calamine Lotion during pregnancy and lactation.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 20/09/2005_
_CRN 2014882_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
None known.
4.9 OVERDOSE
Not applicable
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Not applicable.
5.2 PHARMACOKINETIC PROPERTIES
Not applicable.
5.3 PRECLINICAL SAFETY DATA
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Zinc Oxide
Bentonite
Sodium Citrate
Phenol
Glycerol
Purified Water
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
3 years.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25
o
C.
IRISH MEDICINES BOARD
____________________________________________
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