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Logo DERMADINE ORAL ANTISEPTIC GARGLE AND MOUTHWASH

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

DERMADINE ORAL ANTISEPTIC GARGLE AND MOUTHWASH

COMPOSITION:
Each 100 mL of DERMADINE ORAL ANTISEPTIC contains:
Povidone-iodine 1,00 g (1% m/v) equivalent to 0,1% m/v available iodine.
Contains: 8,85% v/v alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A 16.4 Naso-pharyngeal and bucco-pharyngeal antiseptics.

PHARMACOLOGICAL ACTION:
Povidone-iodine is a multivalent broad spectrum local disinfectant 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.

INDICATIONS:
DERMADINE ORAL ANTISEPTIC
is recommended for relief of painful infections and inflammatory conditions of the mouth and throat and as a routine mouthwash.
INFECTIONS:
Aphthous ulcers, gingivitis, stomatitis and pharyngitis due to superficial infections. It is also recommended for use prophylactically during and after oral surgery.

CONTRA-INDICATIONS:
Sensitivity to Povidone-iodine. Patients with non-toxic nodular colloid goitre should not use Povidone-iodine.

WARNINGS:
Not to be used by persons who are allergic to iodine.
Not to be used in pregnancy or by lactating women.

DOSAGE AND DIRECTIONS FOR USE:
AS A MOUTHWASH:
Dilute one part of DERMADINE ORAL ANTISEPTIC with two parts of water, rinse mouth thoroughly and spit out, or use as directed by physician or dentist.

FOR INFECTIONS OF MOUTH AND THROAT:
Use full strength and rinse or gargle for thirty seconds then spit out, repeat hourly, or as directed by physician or dentist.

FOR CHILDREN UNDER 3 YEARS:
Dilute one part DERMADINE ORAL ANTISEPTIC with three parts water and paint the mouth with the aid of a cotton bud.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Certain individuals may become sensitised to Povidone-iodine. If irritation, swelling or redness occurs, discontinue treatment and consult your physician. If severe or persistent sore throat, or sore throat accompanied by high fever, headache, nausea and vomiting occur, consult your physician promptly, as these symptoms may indicate a serious condition. Absorption of Povidone-iodine may interfere with thyroid function tests.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Should ingestion occur, systemic effects such as metabolic acidosis, hypernatraemia and renal impairment may occur. A doctor should be consulted without delay. Treatment is symptomatic and supportive.

IDENTIFICATION:
DERMADINE ORAL ANTISEPTIC
is a dark-brown aqueous solution with a characteristic iodine smell, and a pleasant flavour.

PRESENTATION:
Bottles of 200 mL and 2,5 litre.

STORAGE INSTRUCTIONS:
Store below 25°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER/APPLICATION NUMBER:
H.1511 (Act 101/1965)

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

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1999

100286 03/2003 Pro-Print

Updated on this site: December 2016
Source: Pharmaceutical Industry
http://www.cipla.co.za/products/over-the-counter/otc-topical/dermadine-oral-antiseptic

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