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 Kroger Co.. 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 120°F. 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

• irritiation occurs
• no improvement within 2 weeks

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
• use daily for two 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 20° and 30°C (68° and 86°F)

Inactive ingredients

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

Questions?

800-632-6900

Principal Display Panel

Kroger

Antifungal

Jock Itch

Powder

Spray

Miconazole Nitrate 2%

Cures Most Jock Itch

Relieves Itching,

Chafing & Burning

Talc-Free

NET WT 4.6 OZ(130g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
jock itch spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-089
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
KAOLIN (UNII: 24H4NWX5CO)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
ISOBUTANE (UNII: BXR49TP611)
ALCOHOL (UNII: 3K9958V90M)
STARCH, CORN (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-089-46	130 g in 1 CAN; Type 0: Not a Combination Product	04/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/01/2018

Labeler - Kroger Co. (006999528)