Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Sad-otc
DENOREX® MEDICATED SHAMPOO SCHEDULING STATUS: Not scheduled PROPRIETARY NAME (and dosage form): DENOREX ® MEDICATED SHAMPOO COMPOSITION: Each 100 g contains: Coal Tar Solution 7,5 g Parachlorometaxylenol 0,5 g PHARMACOLOGICAL CLASSIFICATION: A.13.9.1 Preparations for psoriasis. PHARMACOLOGICAL ACTION: Coal Tar is useful in certain scalp ailments and it helps prevent the growth of scaly cells. Parachlorometaxylenol is a bacteriostatic agent. INDICATIONS: DENOREX SHAMPOO is effective in the control and relief of an itching and inflamed scalp and in the treatment of psoriasis, dandruff and seborrhoea. CONTRA-INDICATIONS: None. WARNINGS: Avoid contact with eyes - in the event of accidental contact rinse thoroughly with water. For external use only. DOSAGE AND DIRECTIONS FOR USE: Wet hair thoroughly and massage DENOREX into hair and scalp until a lather is obtained. Rinse out and repeat. Your scalp will tingle slightly immediately after use. For best results shampoo every second day during the first ten days of treatment. Thereafter twice to three times a week is usually sufficient. For severe scalp problems DENOREX can safely be used every day. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Discontinue if irritation develops. If symptoms persist, consult your doctor. KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: None. IDENTIFICATION: A black -brown liquid with a characteristic odour of coal tar and menthol. PRESENTATION: DENOREX is available in 125 mL plastic bottles. STORAGE INSTRUCTIONS: Store well closed, below 25 °C. KEEP OUT OF REACH OF CHILDREN. REFERENCE NUMBER: REFERENCE NUMBER: G.2195 (Act 101/1965) NAME AND BUSINESS ADDRESS OF APPLICANT: S.A.D. SELF MEDICATION [PTY] LIMITED (Co. Reg. No. 92/04769/07) Robbie de Lange Road Read the complete document