Product information

From Health Canada

The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.

Current status:

Marketed

Current status date:

2012-12-12

Original market date: See footnote 1

1986-12-31

Product name:

MONISTAT 3 DUAL-PAK

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

DIN:

02126249

Product Monograph/Veterinary Labelling:

Date: 2011-11-24 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

INSIGHT PHARMACEUTICALS, LLC
660 White Plains Road
Tarrytown
New York
United States 10591

Class:

Human

Dosage form(s):

Cream ,  Ovule

Route(s) of administration:

Vaginal ,  Topical

Number of active ingredient(s):

2

Schedule(s):

OTC

 

American Hospital Formulary Service (AHFS): See footnote 3

84:04.08.08 

Anatomical Therapeutic Chemical (ATC): See footnote 4

G01AF04 MICONAZOLE

Active ingredient group (AIG) number:See footnote5

0217970001

List of active ingredient(s)
Active ingredient(s) Strength
MICONAZOLE NITRATE 2 %
MICONAZOLE NITRATE 400 MG / SUP
Version 4.0.2
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