Label: DESENEX- miconazole nitrate powder
- NDC Code(s): 0067-0949-15, 0067-0949-30
- Packager: Novartis Consumer Health, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
Miconazole nitrate 2%Close
- cures most athlete’s foot (tinea pedis)
- relieves itching, burning, cracking and discomfort associated with athlete’s foot
For external use onlyClose
- 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.Close
- 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, talcClose
- Questions or comments?
Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622Close
- Principal Display Panel
2% Miconazole Nitrate, Antifungal
Cures Most Athlete’s Foot
Relieves Itching & BurningClose
- Principal Display
- INGREDIENTS AND APPEARANCE
miconazole nitrate powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0067-0949 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0067-0949-15 43 g in 1 CONTAINER 2 NDC:0067-0949-30 85 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/03/2009 Labeler - Novartis Consumer Health, Inc. (879821635)