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 DZA BRANDS LLC. 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.

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

• 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

Other information

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

Inactive ingredient

isobutane (propellent), SD alcohol 40-B (14%w/w), stearalkonium hectorite, talc

Questions?

Call 1-866-964-0939

Principal Display Panel

Healthy Accents

medicated

jock itch

powder spray

miconazole nitrate 2%

antifungal

• cures most symptoms of jock itch
• relieves itching, chafing and burning

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: 55316-120
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
ISOBUTANE (UNII: BXR49TP611)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
ALCOHOL (UNII: 3K9958V90M)
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-120-46	131 g in 1 CAN; Type 0: Not a Combination Product	12/21/2017	05/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/21/2017	05/15/2020

Labeler - DZA BRANDS LLC (090322194)