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 L. Perrigo Company. 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

GoodSense

Medicated

Anti-Fungal

Miconazole Nitrate 2%

Liquid Countinuous Spray

Cures and prevents most athlete's foot

Relief from burning & itching

NET WT 5.3 OZ (151g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
antifungal miconazole liquid continuous spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0113-0136
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: 0113-0136-53	150 g in 1 CANISTER; Type 0: Not a Combination Product	04/13/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/13/2012

Labeler - L. Perrigo Company (006013346)