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

Logo 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 topical application to neonates. Absorption of povidone-iodine may interfere with thyroid function tests.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Ingestion is unlikely but if accidentally ingested systemic effects could include metabolic acidosis, hypernatraemia and renal impairment. These effects could occur if the shampoo were applied to large areas or denuded skin. The patient should be taken to a doctor or the nearest hospital without delay.
Treatment is symptomatic and supportive.

IDENTIFICATION:
BETADINE * MEDICATED SHAMPOO
is an opalescent gold lotion with an apple fragrance.

PRESENTATION:
Plastic squeeze bottles of 150 mL.

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

REGISTRATION / REFERENCE NUMBER:
G1572 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston Ext. 77
Private Bag X69
Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
23 January 1987

Under licence from:
Mundipharma AG, Switzerland
*BETADINE is a Registered Trade Mark

New addition to this site: April 2004
Source: Pharmaceutical Industry

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