Miconazole Nitrate Antifungal Powder Spray

FDA Drug Profile — Miconazole Nitrate

Drug Details

Generic Name
Miconazole Nitrate Antifungal Powder Spray
Brand Names
Miconazole Nitrate
Application Number
M005
Sponsor
Better Living Brands
NDC Codes
1
Dosage Forms
AEROSOL, SPRAY
Routes
TOPICAL
Active Ingredients
MICONAZOLE NITRATE

Indications and Usage

​Uses proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) for effective relief of itching, cracking and burning

Warnings

​Warnings For external use only. Flammable: Contents under pressure. Avoid spraying in eyes. Do not use or store near heat or open flame. Do not puncture or incinerate container. Do not store at temperature above 120°F. Keep out of reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. ​When using this product avoid contact with the eyes or mouth use only as directed ​Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete’s foot and ringworm ​Do not use on children under 2 years of age unless directed by a doctor. ​Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.