MICONAZOLE NITRATE- antifungal miconazole powder spray aerosol, powder

Miconazole nitrate by

Drug Labeling and Warnings

Miconazole nitrate by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole nitrate 2%

​ ​Purpose

Antifungal

Uses

• cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
• relieves symptoms of athlete's foot, including itching burning and cracking

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 120ºF

When using this product

• avoid contact with the eyes or mouth
• use only as directed

Intentional misuse by deliberately concentrating and inhaling contents cans 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.

​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 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 persist, consult a doctor
• this product is not effective on the scalp or nails
• in case clogging, clear nozzle under running water

​Other information

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

​Inactive ingredients

isobutane (propellant), SD alcohol 40-B (10%w/w), stearalkonium hectorite, talc

​ ​Questions?

Call 1-866-964-0939

​Principal Display Panel

Premier

Antifungal
Powder

Spray
Miconazole Nitrate 2%

For athlete's foot

• Cures & prevents most athlete's foot
• Relieves itching & burning

NET WT 4.6 OZ (130g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
antifungal miconazole powder spray aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-302
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
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-302-46	130 g in 1 CANISTER; Type 0: Not a Combination Product	01/01/2013	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2013	12/31/2020

Labeler - Premier Brands of America Inc. (080051232)