INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo BENOXYL 5 LOTION (Topical lotion)

SCHEDULING STATUS
Unscheduled.

PROPRIETARY NAME
(and dosage form)

BENOXYL 5 LOTION (Topical lotion)

COMPOSITION
Active ingredient:
Benzoyl peroxide 5,0g/100 g (as hydrous benzoyl peroxide)

PHARMACOLOGICAL CLASSIFICATION
A.13.12 Acne Preparations

PHARMACOLOGICAL ACTION
Benzoyl peroxide provides control of acne lesions through its antibacterial action, and has a drying and desquamative effect.

INDICATIONS
Benoxyl 5 lotion is indicated for use in the treatment of acne vulgaris.

CONTRAINDICATIONS
Benoxyl 5 lotion should not be prescribed for patients with a known hypersensitivity to benzoyl peroxide.

WARNINGS
Application to sensitive areas such as the neck should be made with caution; to avoid irritation there should be no contact with eyes, mouth and other mucous membranes. Benoxyl 5 Lotion may bleach dyed fabrics.

FOR EXTERNAL USE ONLY.

DOSAGE AND DIRECTIONS FOR USE
Apply the lotion to the affected areas once daily. Washing with soap and water prior to application greatly enhances the efficacy of the preparation.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
In normal use, a mild burning sensation will probably be felt on first application and a moderate reddening and peeling of the skin will occur within a few days. During the first few weeks of treatment a sudden increase in peeling will occur in most patients; this is not harmful and will normally subside in a day or two if treatment is temporarily discontinued.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Excessive topical use may result in erythema and scaling. Emollients should be applied as required.

Accidental ingestion may cause soreness of the mouth and throat, nausea and vomiting. Administer copious quantities of water and antacids as necessary.

IDENTIFICATION
Benoxyl 5 lotion is a white viscous liquid.

PRESENTATION
Benoxyl 5 lotion is supplied in a white polyethylene bottle of 30 mL capacity. The bottle is presented in a carton with a package insert leaflet.

STORAGE INSTRUCTIONS
Store below 25°C.
Keep out of reach of children.

REGISTRATION NUMBER
G2036 (Wet/Act 101/1965)

APPLICANT
Stiefel Laboratories (SA) Pty Limited
20 Julbert Street
Benrose
Johannesburg

DATE OF PUBLICATION
April 1992

STIEFEL        EF86

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