MICONAZOLE NITRATE- miconazole nitrate antifungal powder spray aerosol, spray

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Better Living Brands. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole nitrate 2%

Purpose​

Antifungal

​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

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.

​Directions

• wash affected area and dry thoroughly
• shake can well and spray a thin layer of the product 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
• for athlete’s foot and ringworm, use daily for 4 weeks
• if condition persists, consult a doctor
• this product is not effective on the scalp or nails
• if nozzle clogs, clean with a pin

​Other information

store between 20º and 30ºC (68ºF and 86º)

​ ​Inactive ingredients

disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch

​Questions?

Call 1-866-964-0939

​Principal Display Panel

Signature

Care

Athlete's

Foot Spray

Miconazole Nitrate 2%

Antifungal

Powder Spray

• Cures most athlete's foot
• Relieves itching, cracking

& burning

• Talc-free

NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
miconazole nitrate antifungal powder spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-212
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)
STARCH, CORN (UNII: O8232NY3SJ)
KAOLIN (UNII: 24H4NWX5CO)
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-212-00	130 g in 1 CAN; Type 0: Not a Combination Product	09/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/27/2021

Labeler - Better Living Brands (009137209)