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

Logo BETADINE®ANTISEPTIC CREAM 5%

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form)

BETADINE®ANTISEPTIC CREAM 5%

COMPOSITION:
Each 1 gram contains
povidone-iodine 50 mg, equivalent to 5 mg available iodine in a water-soluble base.

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:
As an antiseptic in:-
Skin infections
Decubitus ulcers
Wounds, cuts and abrasions
Burns
Post-operative wounds.

CONTRA-INDICATIONS:
Sensitivity to povidone-iodine. Patients with a non-toxic nodular colloid goitre should not use povidone-iodine. Application to large areas of broken skin should be avoided as excessive absorption of iodine may occur.

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:
The affected area should be cleaned and dried. Apply BETADINE®ANTISEPTIC CREAM 5% liberally and cover with a dressing or bandage. BETADINE®ANTISEPTIC CREAM 5% may be used as often as required.

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:
Systemic effects include metabolic acidosis, hypernatraemia and renal impairment, and may occur if applied to large areas or to denuded skin. Treatment is symptomatic and supportive.

IDENTIFICATION:
BETADINE®ANTISEPTIC CREAM 5%
is a dark brown cream with a characteristic iodine odour.

PRESENTATION:
500 g jars, 25 g and 100 g tubes.

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

REGISTRATION NUMBER:
S/13.1/46

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 of Mundipharma, A G Switzerland

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

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