MICONAZOLE NITRATE- antifungal liquid continuous spray aerosol, spray

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by HEB. 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 itching, burning and scaling

Warnings

For external use only.

Extremely flammable:

Content under pressure. Keep away from fire, sparks and heated surfaces. Do not punchure or incinerate container. Exposure to temperatures above 120 oF may cause bursting. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

on children under 2 years of age unless directed by a doctor.

When using this product

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

Stop use and ask a doctor if

• no improvement within 4 weeks for athlete's foot and ringworm and 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.

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 condition persist, consult a doctor
• this product is not effective on the scalp or nails

Other information

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

Inactive ingredients

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

Questions?

Call 1-866-964-0939

Principal Display Panel

HEB

Antifungal

Miconazole Nitrate 2%

Liquid Continuous Spray

• Cure Most Athlete's Foot
• Relief from Burning and Itching

NET WT 5.3 OZ (150g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
antifungal liquid continuous spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37808-520
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: 37808-520-53	150 g in 1 CAN; Type 0: Not a Combination Product	01/17/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/17/2012

Labeler - HEB (007924756)