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Logo BETADINE* SURGICAL SCRUB

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

BETADINE* SURGICAL SCRUB

COMPOSITION:
Each 100 mL contains 7,5 g
povidone-iodine (7,5% m/v) equivalent to 0,75 g available iodine.

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:
Disinfection of the hands prior to surgery procedures or in the operating theatre. Preparing the patient's skin prior to surgery procedures or operations. As an antiseptic soap in infected skin conditions. As a general germicidal skin cleanser in consulting rooms.

CONTRA-INDICATIONS:
Sensitivity to povidone-iodine. Patients with non-toxic nodular colloid goiter should not use povidone iodine.

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:
Pre-Operative Washing by Operation Personnel:-
Wet hands with water. Pour sufficient BETADINE* SURGICAL SCRUB onto the palm and spread over both hands. Rub the scrub thoroughly over all areas for two minutes. Use a nail brush, if desirable. Add a little water to develop a copious lather. Rinse thoroughly under running water.
Pre-Operative use on Patients:-
After the area is shaved, wet it with water. Apply BETADINE* SURGICAL SCRUB (1 mL is sufficient to cover about 50 - 75 square cm) and rub in thoroughly for at least two minutes. Use sterile gauze soaked with water to develop a copious lather. Rinse off and dry with dry sterile gauze.
Consulting Room Use:-
Use for washing whenever a germicidal soap is required. For the maximum effect on the hands or patient's skin, proceed as in the above two paragraphs.
NOT FOR DOUCHING PURPOSES

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity and local irritation may occur. 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 surgical scrub were applied to large areas or to denuded skin. The patient should be taken to a doctor or to the nearest hospital without delay. Treatment is symptomatic and supportive.

IDENTIFICATION:
BETADINE* SURGICAL SCRUB
is an amber-coloured foaming liquid with a characteristic iodine smell.

PRESENTATION:
Plastic bottles of 1 litre.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION/REFERENCE NUMBER:
G1571 (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 September 1993

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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