Your browser does not support JavaScript! DESENEX (MICONAZOLE NITRATE) POWDER [NOVARTIS CONSUMER HEALTH, INC.]
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DESENEX (miconazole nitrate) powder
[Novartis Consumer Health, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • cures most athlete’s foot (tinea pedis)
  • relieves itching, burning, cracking and discomfort associated with athlete’s foot

Warnings

For external use only

Do Not Use

  • in the eyes
  • for nail or scalp infections

When using this product

  • do not get into the eyes

Stop use and ask a doctor if

  • irritation occurs or gets worse.
  • no improvement within 4 weeks

Keep Out of Reach of Children

If swallowed, get medical help or contact a poison control center right away.

Directions

  • adults and children 2 years and older
  • wash the affected area with soap and water and dry completely before applying
  • apply a thin layer over affected area twice a day (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • pay special attention to the spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once a day
  • use every day for 4 weeks
  • children under 2 years of age: ask a doctor

Other information

  • store at controlled room temperature 20-25C (68-77F)
  • See container bottom for lot number and expiration date

Inactive ingredients

corn starch, fragrance, talc

Questions or comments?

call 1-800-452-0051

Distributed by:  

Novartis Consumer Health, Inc.

Parsippany, NJ 07054-0622

Principal Display Panel

NDC 0067-0949-30

2% Miconazole Nitrate, Antifungal

Desenex®

Powder

Absorbs Wetness

Cures Most Athlete’s Foot

Relieves Itching & Burning

Principal Display

Desenex Shake Powder 3.0 oz label
DESENEX 
miconazole nitrate powder
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0067-0949
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
TALC 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-0949-1543 g in 1 CONTAINER
2NDC:0067-0949-3085 g in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/03/2009
Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 12/2012
 
Novartis Consumer Health, Inc.

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