MICONAZOLE NITRATE- jock itch spray aerosol, spray

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Dolgencorp, Inc. (DOLLAR GENERAL & REXALL). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

• cures most jock itch (tinea cruris)
• relieves symptoms of jock itch including itching, burning and chafing associated with jock itch

Warnings

For external use only.

When using this product

• do not get into 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 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. Do not use for diaper rash. 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)
• supervise children in the use of this product
• use daily for 2 weeks. If conditions persist, consult a doctor
• this product is not effective on scalp or nails
• in case of clogging, clear nozzle under running water

Inactive ingredient

Disteardimonium Hectorite, Isobutane, Kaolin, SD Alcohol 40-B, Zea Mays (Corn) Starch

Questions?

Call 1-866-964-0939

Principal Display Panel

Rexall

ANTIFUNGAL

Jock Itch

Powder Spray

Miconazole Nitrate 2%

• Cures most jock itch
• Relieves itching, chafing and burning

NET WT 4.6 OZ (130 g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
jock itch spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-841
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	1.3 g  in 130 g

Inactive Ingredients
Ingredient Name	Strength
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOBUTANE (UNII: BXR49TP611)
KAOLIN (UNII: 24H4NWX5CO)
ALCOHOL (UNII: 3K9958V90M)
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-841-46	130 g in 1 PACKAGE; Type 0: Not a Combination Product	07/31/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/31/2017

Labeler - Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) (068331990)