Johnson & Johnson Pacific - Monistat

Published in the Commonwealth of Australia Gazette No. GN 29, 21 July 2004

THERAPEUTIC GOODS ACT 1989

I, PIO CESARIN, Director, Non-Prescription Medicines Branch, Therapeutic Goods Administration and delegate of the Secretary to the Department of Health and Ageing for the purposes of Section 42DF(1) of the Therapeutic Goods Act 1989, give notice that the restricted representations described in paragraph (a) below, have been approved for use in advertisements directed to consumers, for the products listed in paragraph (b) provided the conditions identified in paragraph (c) are met:

1. Representations to the effect that advertisements to consumers for the goods described in paragraph (b) may refer to:
   1. "Monistat is used to treat candidal (thrush) infections of the vagina";
   2. "women who are diabetic are more likely to get repeated thrush infections";
   3. "repeated thrush infections may suggest unrecognised diabetes"; and
   4. "intractable candidiasis (thrush) may be the presenting symptoms of unrecognised diabetes",
2. Monistat 1 Vaginal Ovule and Cream (AUST R 83024);
   Monistat 3 40mg/g Cream with Disposable Applicators (AUST R 83229);
   Monistat 3 Pre-filled Applicators (AUST R 92096; and
   Monistat 7 20mg/g Cream with Disposable Applicators (AUST R 91065),
   sponsored by Johnson & Johnson Pacific Pty Ltd,
3. Where the advertisements which include either or all of the representations in paragraph (a) also include statements to the effect that:
   "if symptoms persist, seek medical advice"; and
   "women experiencing such episodes should seek medical advice"
   as appropriate.

Dated this 8th day of July 2004

PIO CESARIN
Delegate of the Secretary to the Department of Health and Ageing