MICONAZOLE NITRATE 2%- jock itch spray aerosol, spray

Miconazole Nitrate 2% by

Drug Labeling and Warnings

Miconazole Nitrate 2% 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 itching, burning and chafing associated with jock itch

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 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

• do not get into eyes or mouth
• use only as directed

Stop use and ask a doctor if

• irritation occurs
• no improvement within 2 weeks

Do not use

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

Keep out of the 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
• use daily for 2 weeks; if condition persists, consult a doctor
• this product is not effective on the scalp or nails
• if nozzle clogs, clean with a pin

Other Information

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

Inactive ingredients

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

Questions?

Call 1-866-4-REXALL

Principal Display Panel

Since 1903

Rexall

ANTIFUNGAL

Jock Itch

Powder Spray

Miconazole Nitrate 2%

• Cures most jock itch
• Relieves itching, chafing and burning
• Talc-free

NET WT 4.6 OZ (130g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 2% 
jock itch spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-164
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 131 g

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
KAOLIN (UNII: 24H4NWX5CO)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-164-46	131 g in 1 CAN; Type 0: Not a Combination Product	06/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/03/2019

Labeler - Dolgencorp, Inc. (Dollar General & Rexall) (068331990)