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

Logo BETADINE* ANTISEPTIC SOLUTION

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form)::

BETADINE* ANTISEPTIC SOLUTION

COMPOSITION:
Each 1 mL contains 100 mg
povidone-iodine, equivalent to 10 mg 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 virusses, protozoa, yeasts, cysts and spores are also susceptible.

INDICATIONS:
Disinfection of wounds, lacerations, abrasions and burns. Prophylaxis against infection in hospital and surgery procedures.
Preparation of skin and mucous membranes prior to surgery. Post- operative application to protect against infection. Treatment of infected skin conditions.

CONTRA-INDICATIONS:
Hypersensitivity to povidone-iodine.
Povidone-iodine solutions should not be used on patients with a non-toxic nodular colloid goiter.
Application to large areas of broken skin should be avoided as excessive absorption of iodine may occur.
Absorption of povidone-iodine may interfere with thyroid function tests

WARNINGS:
1. Not to be used by persons who are allergic to iodine.
2. Not be used in pregnancy or by lactating women.

DOSAGE AND DIRECTIONS FOR USE:
Apply full strength, as a paint, or soak or spray as often as needed.
Shake the bottle before use and clean the nozzle of the spray pump after use.
NOT FOR DOUCHING PURPOSES

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Local irritation and sensitivity 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:
Systemic effects include metabolic acidosis, hypernatraemia and renal impairment. These effects could occur if the solution is 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* ANTISEPTIC SOLUTION
is an amber-coloured aqueous solution with a characteristic iodine smell.

PRESENTATION:
Plastic pump spray bottle containing 100 mL solution and 1 litre plastic containers.

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

REGISTRATION/REFERENCE NUMBER:
G1570 (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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