Label: MICONAZOLE NITRATE- antifungal liquid continuous spray aerosol, spray
- NDC Code(s): 68016-516-00
- Packager: Chain Drug Consortium, LLC
- 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 January 25, 2023
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- Active ingredient
For external use only.
Do not use while smoking or near heat or flame. Do not puncture or incinerate, contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.
Stop use and ask a doctor if
- no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch
- irritation occurs
- wash affected area and dry thoroughly
- shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor
- supervise children in the use of this product
- for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
- for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
- if conditions persist, consult a doctor
- this product is not effective on the scalp or nails
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
antifungal liquid continuous spray aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-516 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 3 g in 150 g Inactive Ingredients Ingredient Name Strength ACETONE (UNII: 1364PS73AF) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) ALCOHOL (UNII: 3K9958V90M) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-516-00 150 g in 1 CAN; Type 0: Not a Combination Product 01/05/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/05/2010 Labeler - Chain Drug Consortium, LLC (101668460)