Label: DESENEX- miconazole nitrate powder
- NDC Code(s): 0316-0225-15, 0316-0225-30
- Packager: Crown Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: 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 Information
Updated February 21, 2022
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- Official Label (Printer Friendly)
- Active ingredient
For external use only · Avoid contact with eyes.
- adults and children 2 years and older
- wash the affected area with soap and water and dry thoroughly 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
- Inactive ingredients
- Questions or comments?
New & Improved
Miconazole Nitrate 2% Antifungal Treatment
TRIPLE ACTION POWDER
Relieves Itching & Burning
Cures Most Athlete's Foot
NET WT. 3 oz (85 g)
PRODUCT PACKAGED BY WEIGHT NOT VOLUME
©2020 Crown Laboratories, Inc.
Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604
DESENEX is a registered trademark of Crown Laboratories, Inc.
INGREDIENTS AND APPEARANCE
miconazole nitrate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0316-0225 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) CHLOROXYLENOL (UNII: 0F32U78V2Q) IMIDUREA (UNII: M629807ATL) ALDIOXA (UNII: 8T66I31YNK) SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-0225-15 43 g in 1 CONTAINER; Type 0: Not a Combination Product 12/01/2018 2 NDC:0316-0225-30 85 g in 1 CONTAINER; Type 0: Not a Combination Product 12/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/03/2009 Labeler - Crown Laboratories (079035945)