BETADINE ANTISEPTIC OINTMENT povidone-iodine 100mg/g tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

povidone-iodine, Quantity: 100 mg/g (Equivalent: iodine, Qty 10 mg/g)

Available from:

Sanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare

INN (International Name):

povidone-iodine

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: sodium bicarbonate; macrogol 1000; macrogol 3350; macrogol 400; purified water; macrogol 1500

Administration route:

Topical

Units in package:

65g, 25g

Prescription type:

Not scheduled. Not considered by committee

Therapeutic indications:

For the treatment of common skin infections. E.g. infections of the skin around the nails, cold sores and prevention of infections in minor burns, cuts and abrasions. Betadine Antiseptic Ointment is a bactericidal antiseptic.

Product summary:

Visual Identification: A brown viscous ointment; Container Type: Tube; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-25

Patient Information leaflet

BETADINE ANTISEPTIC TOPICAL OINTMENT
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ACTIVE INGREDIENT: _povidone iodine_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
Betadine Antiseptic Topical Ointment. YOU SHOULD ALSO
SPEAK TO YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE
FURTHER INFORMATION OR IF YOU HAVE ANY CONCERNS OR
QUESTIONS ABOUT USING BETADINE ANTISEPTIC TOPICAL
OINTMENT.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using Betadine Antiseptic Topical Ointment?
2. What should I know before I use Betadine Antiseptic Topical
Ointment?
3. What if I am taking other medicines?
4. How do I use Betadine Antiseptic Topical Ointment?
5. What should I know while using Betadine Antiseptic Topical
Ointment?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING BETADINE ANTISEPTIC
TOPICAL OINTMENT?
BETADINE ANTISEPTIC TOPICAL OINTMENT CONTAINS THE ACTIVE
INGREDIENT POVIDONE.
BETADINE ANTISEPTIC TOPICAL OINTMENT IS USED AS AN
ANTISEPTIC FOR THE TREATMENT OF COMMON SKIN INFECTIONS
SUCH AS INFECTIONS OF THE SKIN AROUND THE NAILS,
PREVENTION OF INFECTIONS IN MINOR BURNS, CUTS AND
ABRASIONS.
2.
WHAT SHOULD I KNOW BEFORE I USE BETADINE
ANTISEPTIC TOPICAL OINTMENT?
WARNINGS
BETADINE ANTISEPTIC TOPICAL OINTMENT IS FOR
EXTERNAL USE ONLY.
DO NOT USE BETADINE ANTISEPTIC TOPICAL OINTMENT:
•
if you are allergic to povidone or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use
this medicine.
•
on extensive burn areas
•
if you have a known hypersensitivity to povidone iodine,
iodine polyvinylpyrrolidone or any excipients listed in the
product description.
•
if irritation, redness or swelling develops, discontinue
treatment and consult a doctor.
•
if you currently have or have ever had, a thyroid problem,
including swelling (nodular colloid goitre, endemic goitre
or Hashimoto’s thyroiditis), as there may be a risk of
developing hyperthyroidism from the administration o