MICONAZOLE NITRATE- jock itch spray talc free aerosol, spray

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Premier Brands of America Inc. 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

Inactive ingredient

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

Questions?

Call 1-866-964-0939

Principal Display Panel

Premier

Jock Itch Powder Spray

Miconazole Nitrate Antifungal

Cures most jock itch

Relieves itching, chafing and burning

TALC-FREE

NET WT 4.6 OZ (130g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
jock itch spray talc free aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-038
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: 56104-038-46	130 g in 1 PACKAGE; Type 0: Not a Combination Product	06/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	06/10/2017

Labeler - Premier Brands of America Inc (080051232)

Registrant - Premier Brands of America Inc (063849780)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Brands of America Inc		080051232	relabel(56104-038) , repack(56104-038)

Establishment
Name	Address	ID/FEI	Business Operations
American Spraytech LLC		137135237	manufacture(56104-038)