Label: ANTIFUNGAL ATHLETES FOOT- miconazole nitrate aerosol, powder
- NDC Code(s): 79481-0505-1
- Packager: Meijer Distribution Inc
- 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 August 16, 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 can 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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.
- 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
- use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch; if conditions persists, consult a doctor
- this product is not effective on the scalp or nails
- if nozzle clogs, clean with a pin
- Other information
- Inactive ingredients
- Principal Display Panel
INGREDIENTS AND APPEARANCE
ANTIFUNGAL ATHLETES FOOT
miconazole nitrate aerosol, powder
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0505 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 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:79481-0505-1 130 g in 1 CAN; Type 0: Not a Combination Product 08/16/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 08/16/2023 Labeler - Meijer Distribution Inc (006959555)