MICONAZOLE NITRATE- antifungal miconazole liquid continuous spray aerosol, spray

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

Warnings

For external use only.

Extremely 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

• no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch
• irritation occurs

​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
• for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if conditions persist, consult a doctor
• this product is not effective on the scalp or nails

​Other information

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

​Inactive ingredients

acetone, ethoxyglycol, propylene glycol, SD alcohol 40-B (74%w/w), tocopheryl acetate

​ ​Questions?

call 1-866-964-0939

​Principal Display Panel

Premier ​

Medicated

Antifungal

Continuous Liquid Spray

Miconazole Nitrate 2%

 Sprays At Any Angle!

• Cures and prevents most Athletes Foot
• Relieves itching and burning

NET WT 5.3 FL OZ (150g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
antifungal miconazole liquid continuous spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-141
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	3 g  in 150 g

Inactive Ingredients
Ingredient Name	Strength
ACETONE (UNII: 1364PS73AF)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-141-53	150 g in 1 CANISTER; Type 0: Not a Combination Product	01/01/2013

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

Labeler - Premier Brands of America Inc. (080051232)