Betadine Antiseptic

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Povidone-iodine 10%{relative} equivalent to 1% w/w iodine

Available from:

sanofi-aventis new zealand limited

INN (International Name):

Povidone-iodine 10% w/w (=1% w/w iodine)

Dosage:

10% w/w

Pharmaceutical form:

Topical ointment

Composition:

Active: Povidone-iodine 10%{relative} equivalent to 1% w/w iodine Excipient: Macrogol 1000 Macrogol 1500 Macrogol 3350 Macrogol 400 Purified water Sodium bicarbonate

Units in package:

Tube, 1x25g, 25 g

Class:

General sale

Prescription type:

General sale

Manufactured by:

International Speciality Products

Therapeutic indications:

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

Product summary:

Package - Contents - Shelf Life: Tube, 1x25g - 25 g - 24 months from date of manufacture stored at or below 25°C - Tube, 1x65g - 65 g - 24 months from date of manufacture stored at or below 25°C

Authorization date:

1979-12-04

Patient Information leaflet

Betadine Antiseptic Topical Ointment®
1
BETADINE ANTISEPTIC TOPICAL OINTMENT®
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 of large amounts of iodine.
�