COMPOSITION: Each 1 g 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. In- vitro studies have also shown some anti-viral activity.
INDICATIONS: As an antiseptic in minor:
Skin infections
Wounds, cuts and abrasions
Burns
CONTRA-INDICATIONS: Sensitivity to povidone-iodine. Patients with 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* FIRST AID CREAM liberally and cover with a dressing or bandage. BETADINE* FIRST AID CREAM may be used as often as required.
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 TREATMENT: Systemic effects include metabolic acidosis, hypernatraemia and renal impairment . These effects could occur if applied to large areas or denuded skin. Treatment is symptomatic and supportive.
IDENTIFICATION: BETADINE* FIRST AID CREAM is a dark brown cream with a characteristic iodine odour.
PRESENTATION: Tubes containing 20 g cream
STORAGE INSTRUCTIONS: Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER: 27/13.1/0062
NAME AND BUSINESS ADDRESS OF THE APPLICANT: ADCOCK INGRAM LIMITED
Adcock Ingram Park
17 Harrison Avenue
Bryanston
2152
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 24 November 1992
Under licence from:
Mundipharma AG, Switzerland
* BETADINE is a Registered Trade Mark of Mundipharma AG, Switzerland
New addition to this site: April 2004
Source: Pharmaceutical Industry
BETADINE* FIRST AID CREAM