MICONAZOLE NITRATE- anti fungal micoanzole powder spray aerosol, spray

Miconazole Nitrate by

Drug Labeling and Warnings

Miconazole Nitrate by is a Otc medication manufactured, distributed, or labeled by Cardinal Health Inc., Premier Brands of America Inc., American Spraytech L.L.C. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconozole nitrate2%

Purpose

Antifungal

INDICATIONS & USAGE

Uses

• cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
• relieves symtoms of athlete's foot, including itching, burning and cracking

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 120o F

When using this product

• do not get into eyes or mouth
• use only as directed Intentional misues by deliberatley concentrating and inhaling comtents can be harmful or fatal

Stop use and ask a doctor if

• irritation occurs
• no improvement within 4 weeks for athlete's foot and ringworm; 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 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
• for athlete's foot, pay special attention to spaces between toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if condition persists, consult a doctor
• this product is not effective on scalp or nails
• in case of clogging, clear nozzle under running water

Other infomation

Store between 20o and 30o C (68o and 86o F)

Inactive ingredients

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

Questions

Call 1-866-964-0939

PRINCIPAL DISPLAY PANEL

Leader

Medicated

Miconazole Nitrate 2%

Powder Spray

• Cures Most Jock Itch 
• Relieves Itching, Chafing and Burning

NET WT 4.6 OZ (130g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
anti fungal micoanzole powder spray aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-998
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2.6 g  in 130 g

Inactive Ingredients
Ingredient Name	Strength
ISOBUTANE (UNII: BXR49TP611)
ALCOHOL (UNII: 3K9958V90M)	18.2 g  in 130 g
TALC (UNII: 7SEV7J4R1U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-998-66	130 g in 1 CANISTER; Type 0: Not a Combination Product	03/15/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	03/15/2010

Labeler - Cardinal Health Inc. (097537435)

Registrant - Premier Brands of America Inc. (063849780)

Establishment
Name	Address	ID/FEI	Business Operations
Premier Brands of America Inc.		080051232	relabel(37205-998) , repack(37205-998)

Establishment
Name	Address	ID/FEI	Business Operations
American Spraytech L.L.C		137135237	manufacture(37205-998)