Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Sad-otc
DRY & CLEAR® 10 SCHEDULING STATUS: Not scheduled PROPRIETARY NAME (and dosage form): DRY & CLEAR ® 10 COMPOSITION: Each 100 g contains: Hydrous Benzoyl Peroxide equivalent to 10 g Benzoyl Peroxide in a cream base. PHARMACOLOGICAL CLASSIFICATION: A.13.12 Acne preparations. PHARMACOLOGICAL ACTION: Benzoyl Peroxide has keratolytic and anti-seborrhoeic properties. INDICATIONS: The treatment of acne vulgaris and acne rosacea. CONTRA-INDICATIONS: Sensitivity to Benzoyl Peroxide. DOSAGE AND DIRECTIONS FOR USE: FOR EXTERNAL USE ONLY. Cleanse affected areas with mild soap before use. On first day, apply only once to one or two blemished areas. If no discomfort or reaction occurs, apply to affected areas one to three times per day. If these conditions persist, discontinue use and consult your doctor. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: KEEP AWAY FROM THE EYES. A stinging or burning sensation may occur on initial use, but should disappear on continued use. Contact dermatitis may occur in sensitive patients. See also dosage and directions for use. Avoid contact with eyes, lips and mouth and apply with caution to the neck. If skin irritation develops, discontinue use and consult your doctor. If acne condition persists consult your doctor. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: None. IDENTIFICATION: White smooth viscous cream. PRESENTATION: 25 mL polyethylene tube. STORAGE INSTRUCTIONS: Store in a cool place (below 25°C) and keep well closed. KEEP THIS AND ALL MEDICINES OUT OF REACH OF CHILDREN. REGISTRATION NUMBER: N/13.12/170 NAME AND BUSINESS ADDRESS OF APPLICANT: S.A.D SELF MEDICATION [PTY] LIMITED S.A.D SELF MEDICATION [PTY] LIMITED (Co. Reg. No. 92/04769/07) Robbie de Lange Road, Wilsonia, EAST LONDON 5201 DATE OF PUBLICATION OF PACKAGE INSERT: [undate Read the complete document