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

Logo DRYGEL

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

DRYGEL

COMPOSITION:
Each 30 g contains
3,0 g
Povidone-Iodine which is equivalent to 1% in available iodine, in a water miscible base.

PHARMACOLOGICAL CLASSIFICATION:
A 14.1 Wound disinfectants.

PHARMACOLOGICAL ACTION:
Povidone-Iodine is an iodofore which slowly liberates inorganic iodine in contact with the skin and mucous membranes. Iodine is microbiocidal against most bacteria, fungi, protozoa, viruses and yeasts.

INDICATIONS:
Povidone-Iodine gel is used as a general antiseptic in the treatment of skin infections, wounds, cuts, abrasions, burns if not extensive, bedsores, mouth ulcers and post operative wounds.

CONTRA-INDICATIONS:
Drygel is contra-indicated in patients hypersensitive to iodine. Not to be used by pregnant or lactating females.

WARNINGS:
Application of Povidone-Iodine to large areas of broken skin should be avoided as excessive absorption may occur. Absorption of iodine from Povidone-Iodine may interfere with tests of thyroid function.
FOR EXTERNAL USE ONLY.
KEEP OUT OF REACH OF CHILDREN.

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

Note: Apply thinly and leave to dry for 5 minutes. Drygel does not stain clothes and can easily be washed off with soap water.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Hypersensitivity reactions may occur such as irritation, fever and skin eruptions in which case use should be discontinued immediately. Iodine may be absorbed, especially from extensive raw surfaces.
The application of Povidone-Iodine to severe burns or large areas otherwise denuded of skin may produce the systematic adverse effects associated with iodine.

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

IDENTIFICATION:
Drygel is a smooth amber coloured gel with a characteristic iodine odour.

PRESENTATION:
30 g LDPE tubes and 500 g HDPE jars.

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

REGISTRATION NUMBER:

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Compu Pharmaceutical Products Limited
Suite 115
476 Kings Highway
Lynnwood
Pretoria
0081

DATE OF PUBLICATION OF THIS PACKAGE INSERT:

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