Label: MICONAZOLE NITRATE- anti-fungal miconazole athletes foot spray talc free aerosol, powder
- 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.
Updated December 3, 2019
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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
- irritation occurs
- no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch
- wash affected area and dry thoroughly
- shake can well and spray a thin layer over affected area twice daily (morning and night)
- 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
- use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if conditions persist, consult a doctor
- this product is not effective on the scalp or nails
- in case clogging, clear nozzle under running water
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
anti-fungal miconazole athletes foot spray talc free aerosol, powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41520-565 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2.6 g in 130 g Inactive Ingredients Ingredient Name Strength DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ISOBUTANE (UNII: BXR49TP611) KAOLIN (UNII: 24H4NWX5CO) ALCOHOL (UNII: 3K9958V90M) ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41520-565-46 130 g in 1 CAN; Type 0: Not a Combination Product 10/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 10/20/2017 Labeler - Foodhold USA (809183973)