ANTI-FUNGAL POWDER MICONAZOLE NITRATE- miconazole nitrate powder

Anti-fungal Powder Miconazole Nitrate by

Drug Labeling and Warnings

Anti-fungal Powder 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 under 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.

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, & change shoes & 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, micocrystalline cellulose, tricalcium phosphate, zea mays (corn) starch

Questions?

call 1-866-964-0939

Principal Display Panel

EndZone

ANTIFUNGAL

POWDER

MICONAZOLE NITRATE 2%/ANTIFUNGAL

CURES MOST ATHLETE'S FOOT,

JOCK ITCH & RINGWORM

Absorbs Moisture

Relieves itching, Burning,

Scaling & Chafing

Talc-Free

NET WT. 2.5 OZ. (71 g)

INGREDIENTS AND APPEARANCE

ANTI-FUNGAL POWDER MICONAZOLE NITRATE 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56104-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALDIOXA (UNII: 8T66I31YNK)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56104-500-00	71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/12/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/12/2023

Labeler - Premier Brands of America Inc. (063849780)