INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
DERMADINE ANTISEPTIC OINTMENT

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

DERMADINE ANTISEPTIC OINTMENT

COMPOSITION:
Each 25 g contains 2,5 g Povidone-iodine which is equivalent to 1% of available iodine, in a water miscible base.

PHARMACOLOGICAL CLASSIFICATION:
A 14.1 Wound disinfectants.

PHARMACOLOGICAL ACTION:
Povidone-iodine is a multi-valent broad spectrum local disinfectant having bactericidal and fungicidal properties. The effect on vegative cells of various bacteria and fungi is due to the liberation of free iodine from the complex.

INDICATIONS:
DERMADINE ANTISEPTIC OINTMENT is used as a general antiseptic in the treatment of skin infections, wounds, cuts, abrasions, burns if not extensive, bedsores and for post-operative wounds.

CONTRA-INDICATIONS:
Sensitivity to povidone-iodine. Application to large areas of broken skin (e.g. severe and extensive burns) should be avoided as excessive absorption of iodine may occur. Not to be used during pregnancy or by lactating women.

WARNINGS:
Not to be used by persons allergic to iodine.

DOSAGE AND DIRECTIONS FOR USE:
The affected area should be cleaned and dried. Apply to affected areas twice daily or as directed. An occlusive dressing may be used if necessary.

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.
NOTE:
Stains on synthetic fabrics may be removed by washing and rinsing in dilute ammonia.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Systemic effects including metabolic acidosis, hypernatraemia and renal impairment may follow the application of povidone-iodine to severe burns or large areas otherwise denuded of skin. Treatment is symptomatic and supportive.

IDENTIFICATION:
A smooth, amber coloured ointment with a characteristic iodine odour.

PRESENTATION:
25 g and 50 g tubes and 500 g jar.

STORAGE INSTRUCTIONS:
Store at a temperature not exceeding 25°C.
Keep tightly closed
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H.1049 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF APPLICANT:
MEDPRO PHARMACEUTICA (PTY) LTD
UNIT 9 ROSEN HEIGHTS
PASITA STREET
ROSENPARK 7530

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1975

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