MICONAZOLE NITRATE- anti-fungal powder miconazole nitrate talc free powder

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

for the cure of most athlete's foot, jock itch and ringworm

Warnings

For external use only.

Do not use

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

When using this product

avoid contact with the eyes

Stop and ask a doctor if

irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 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

• clean the affected area and dry thoroughly
• apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
• supervise children in the use of this product
• for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if conditions persist longer, consult a doctor
• this product is not effective on the scalp or nails

Other information

• store between 59º - 86ºF
• lightly shake bottle to loosen settled powder

Inactive ingredients

allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

Questions?

call 1-866-964-0939

Principal Display Panel

Premier

Miconazorb AF

Miconazole Nitrate 2%

Talc-Free

NET WT 2.5 OZ (71 g)

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE 
anti-fungal powder miconazole nitrate talc free powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	1.42 g  in 71 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-039-25	71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/03/2017

Labeler - Premier Brands of America Inc. (080051232)