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
Drug Label Information
Updated February 1, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- INDICATIONS & USAGE
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Warnings
For external use only.
Flammable:
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.
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Directions
- 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
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTIFUNGAL MICONAZOLE
miconazole nitrate aerosol, sprayProduct 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 Drug M005 09/29/2021 Labeler - Premier Brands of America Inc. (117557458)