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

Logo STERIDINE MOUTHWASH AND GARGLE LIQUID

SCHEDULING STATUS:
Not scheduled

PROPRIETARY NAME
(and dosage form):

STERIDINE MOUTHWASH AND GARGLE LIQUID

COMPOSITION:
Each 100 mL contains 1,00 g
povidone-iodine equivalent to 0,1% m/v available iodine. Contains 8,5% v/v alcohol.

PHARMACOLOGICAL CLASSIFICATION:
A 16.4 Naso-Pharyngeal and Bucco-Pharyngeal Antiseptics.

PHARMACOLOGICAL ACTION:
Povidone-iodine is an iodophore which slowly reduces iodine from the complex and use used as a disinfectant and antiseptic. It has bactericidal and fungicidal properties and is also effective against viruses, protozoa, cysts and spores.

INDICATIONS:
For the relief of painful infections, and inflammatory conditions of the mouth and pharynx.
As a mouthwash for routine use.
Prophylaxis during and after oral surgery.

CONTRA-INDICATIONS:
Patients with nodular goitres or the history of thyroid disease should not use povidone-iodine.
Hyper-sensitivity to povidone-iodine.

DOSAGE AND DIRECTIONS FOR USE:
Iodine may erode metal. Remove any dental devices containing metal parts prior to rinsing when this product is used routinely.
Not to be used during pregnancy or by lactating females.
Not to be used by persons who are allergic to iodine.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Mouthwash: Dilute one part Steridine Mouthwash and gargle with two parts water, rinse mouth thoroughly and expel remainder.
Infections of mouth and throat: Use full strength, rinse or gargle for 30 seconds and expel remainder. Repeat every hour.
For children under 3 years: Dilute one part Steridine Mouthwash and gargle with three parts water, paint the mouth using a cotton-bud.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The symptoms of acute poisoning from the ingestion of iodine are a disagreeable metallic taste, vomiting, abdominal pain and diarrhoea. Anuria may occur 1 to 3 days later, death may be due to circulatory failure, oedema of the glottis resulting in asphyxia, aspiration, pneumonia or pulmonary oedema. Oesophageal stricture may occur if the patient survives the acute stage. For treatment of acute poisoning, give the patient copious draughts of milk and starch mucilage and lavage may be attempted if there is no oesophageal damage. The patient should be taken to a doctor immediately and treatment should be symptomatic and supportive.

IDENTIFICATION:
A dark red brown to yellow coloured liquid with characteristic menthol smell and taste.

PRESENTATION:
Bottles (glass or plastic) of 200 mL or 500 mL plastic bottles.

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

REGISTRATION NUMBER:
33/16.4/0261

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Xeragen Laboratories (Pty) Ltd
Units 8/11 Glen Park Industrial
1 Highdale Road,
Glen Anil
4051

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 2001

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New addition to this site: March 2004

Source: Pharmaceutical Industry

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