ANTIFUNGAL MICONAZOLE- miconazole nitrate aerosol, spray

Antifungal Miconazole by

Drug Labeling and Warnings

Antifungal Miconazole 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

Miconozole nitrate 2%

Purpose

Antifungal

INDICATIONS & USAGE

Uses

• cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
• relieves symtoms 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 120°F. Intentional misuse by deliberately concentrationg and inhaling 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; 2 weeks for jock itch

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 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

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

Inactive ingredients

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

Questions

Call 1-866-964-0939

PRINCIPAL DISPLAY PANEL

Athlete's Foot Antifungal Powder Spray

Miconazole Nitrate 2%/

ANTIFUNGAL

Cures Most Athelete's Foot

Relieves Itching, Cracking & Burning

Talc Free

NET WT. 4.6 OZ (130g)

INGREDIENTS AND APPEARANCE

ANTIFUNGAL MICONAZOLE 
miconazole nitrate aerosol, spray

Product 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. (063849780)