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

Logo ZEDCHEM PVP-I CREAM (CREAM)
SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

ZEDCHEM PVP-I CREAM (CREAM)

COMPOSITION:
Each 1g contains 50 mg of povidone-iodine, equivalent to 5mg of available iodine.

PHARMACOLOGICAL CLASSIFICATION:
A13.1 Antiseptics and Cleansing Agents.

PHARMACOLOGICAL ACTION:
Povidone-iodine has antiseptic properties.

INDICATIONS:
As an antiseptic for minor skin infections, abrasions, cuts, wounds, burns, decubitus ulcers and postoperative wounds.

CONTRA-INDICATIONS:
Sensitivity to povidone-iodine or other iodine containing products. Avoid application to large areas of broken skin as excessive absorption may occur. Should not be used on patients with non-toxic nodular colloid goitre or during pregnancy and lactation.

WARNINGS:
For external use only.

DOSAGE AND DIRECTIONS FOR USE:
Clean and dry the affected area. Apply Zedchem PVP-I Cream liberally, at least once every 24 hours or as directed by a doctor, and cover with a dressing or bandage.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The application of povidone-iodine to severe burns or to large areas of broken skin, may produce systemic adverse effects associated with iodine. Local irritation and hypersensitivity may occur. Should irritation, swelling or redness occur discontinue treatment and consult a doctor. Hypothyroidism may result after topical application to neonates. Absorption of iodine may interfere with thyroid function tests.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Renal impairment, hypernatremia and metabolic acidosis may occur if applied to large areas of denuded skin. Treatment is symptomatic and supportive.

IDENTIFICATION:
Zedchem PVP-I Cream is a brown cream with a characteristic iodine odour.

PRESENTATION:
25g tubes; 100g tubes; 500g jars.

STORAGE INSTRUCTIONS:
Keep well closed and store below 25°C. Keep out of reach of children.

REGISTRATION NUMBER:
27/13.1/0053

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
ZEDCHEM cc (Reg. No CK 92/22113/23)
Pama House
Main Road P.O. Box 116
STEENBERG STEENBERG
7945 7947
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
15 April 1993

        P603

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