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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acetoxyl 5 Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrous Benzoyl Peroxide equivalent to Benzoyl peroxide 5%w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Gel
A white gel, free from gritty particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acetoxyl 5 Gel is indicated for the treatment of mild to moderate acne vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
Adults
Apply to the whole of the affected area once or twice daily. Wash with soap and water prior to application.
Paediatric use
The safety and efficacy of Acetoxyl 5 Gel has not been established in children since acne vulgaris rarely presents in this
age group.
Elderly patients
There are no specific recommendations. Acne vulgaris does not present in the elderly.
4.3 CONTRAINDICATIONS
Patients with known hypersensitivity to any of the ingredients should not use the product.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Avoid contact with the eyes, mouth and other mucous membranes. Care should be taken when applying the product to
the neck and other sensitive areas.
The product may bleach coloured or dyed fabrics.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 05/07/2006_
_CRN 2025170_
_page number: 1_
4.6 PREGNANCY AND LACTATION
The safety of benzoyl peroxide in human pregnancy is established. There are no restrictions on the use of Acetoxyl 5
Gel during pregnancy and lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
4.8 UNDESIRABLE EFFECTS
In normal use, a mild burning sensation will probably be felt on first application and a mode
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