Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
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BETADINE* MEDICATED SHAMPOO SCHEDULING STATUS: Not scheduled PROPRIETARY NAME (and dosage form): BETADINE* MEDICATED SHAMPOO COMPOSITION: Each 100 mL contains povidone-iodine , 4,0 g (4% m/v) equivalent to 0,4 g available iodine, in a shampoo base with conditioner. PHARMACOLOGICAL CLASSIFICATION: A 13.1 Antiseptics, Disinfectants, Cleansing agents PHARMACOLOGICAL ACTION: Povidone-iodine is a multivalent broad spectrum local antiseptic having bactericidal and fungicidal properties. The effect on vegetative cells of various bacteria and fungi is due to the liberation of free iodine from the complex. Many viruses, protozoa, yeasts, cysts and spores are also susceptible. INDICATIONS: Seborrhoeic conditions of the scalp associated with excessive dandruff, pruritis, scaling, exudation and erythema. Pityriasis capitis. Infected lesions of the scalp - pyodermas (furunculosis, infective folliculitis and impetigo). CONTRA-INDICATIONS: Sensitivity to iodine. Povidone-iodine should not be used on patients with non-toxic nodular colloid goitre. WARNINGS: 1. Not to be used by persons who are allergic to iodine. 2. Not to be used in pregnancy or by lactating women. DOSAGE AND DIRECTIONS FOR USE: After wetting the hair apply an adequate amount of the shampoo, using warm water to lather. Rinse. Repeat the application and massage into the scalp with the fingertips. Allow to remain on the scalp for at least five minutes. Again work up a lather and rinse thoroughly. Repeat the treatment at least twice weekly until improvement is noted. Afterwards use BETADINE * MEDICATED SHAMPOO once a week. SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Hypersensitivity and local irritation may occur. However, if irritation, swelling or redness occur, discontinue treatment and consult your physician. Hypothyroidism may occur after Read the complete document