Label: ANTIFUNGAL MICONAZOLE- miconazole nitrate aerosol, spray
- NDC Code(s): 56104-256-01
- Packager: Premier Brands of America 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 January 25, 2023
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- Active ingredient
- INDICATIONS & USAGE
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 120°F. Intentional misuse by deliberately concentrationg 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
- 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 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 condition persists, consult a doctor
- this product is not effective on scalp or nails
- if nozzle clogs, clean with a pin
- Other infomation
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
miconazole nitrate aerosol, spray
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56104-256 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 ISOBUTANE (UNII: BXR49TP611) ALCOHOL (UNII: 3K9958V90M) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8) KAOLIN (UNII: 24H4NWX5CO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56104-256-01 130 g in 1 CANISTER; Type 0: Not a Combination Product 11/02/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/29/2021 Labeler - Premier Brands of America Inc. (117557458)