Calamine Lotion, cutaneous suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zinc oxide; Calamine

Available from:

Ovelle Limited

ATC code:

D02AB

INN (International Name):

Zinc oxide; Calamine

Dosage:

15 %w/v + 5 percent weight/volume

Pharmaceutical form:

Cutaneous suspension

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Zinc products

Authorization status:

Marketed

Authorization date:

1992-10-14

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Calamine Lotion, cutaneous suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Calamine 15% w/v
Zine Oxide 5% w/v
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Cutaneous Suspension.
Calamine Lotion is a pale pink lotion which separates on standing.
It has a faint characteristic odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Calamine Lotion is a mild astringent lotion recommended for the
topical treatment of mild skin irritation and
inflammation, including mild sunburn.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Calamine Lotion is applied topically to the affected area with cotton
wool and allowed to dry.
4.3 CONTRAINDICATIONS
Calamine Lotion is contraindicated in patients with a known
sensitivity to its ingredients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
No adverse effects reported.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Zinc oxide is incompatible with benzylpenicillin. Zinc oxide reacts
slowly with fatty acid in oils and fats to produce the
corresponding fatty acid esters.
4.6 FERTILITY, PREGNANCY AND LACTATION
No adverse effects reported.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No adverse effects reported.
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4.8 UNDESIRABLE EFFECTS
None reporte