ANTIFUNGAL POWDER- miconazole nitrate powder

Antifungal Powder by

Drug Labeling and Warnings

Antifungal Powder by is a Otc medication manufactured, distributed, or labeled by LEADER/ Cardinal Health 110, 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, ringworm and chafing associated with jock itch

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 the 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 & 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

Zea Mays (Corn) Starch, Tricalcium Phosphate, Microcrystalline Cellulose, Sodium Bicarbonate, Allantoin, Chloroxylenol, Fragrance

Questions?

call 1-866-964-0939

Principal Display Panel

LEADER

Moisture Absorbing

Antifungal

Powder

Miconazole Nitrate 2%/

Antifungal

Cures Most Athlete's Foot

Relieves Itching, Burning

& Scaling

Absorbs Moisture

COMPARE TO

ZEASORB AF

active ingredient

NET WT 2.5 OZ (71 g)

INGREDIENTS AND APPEARANCE

ANTIFUNGAL POWDER 
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0679
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
ALLANTOIN (UNII: 344S277G0Z)
CHLOROXYLENOL (UNII: 0F32U78V2Q)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0679-1	71 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/16/2024

Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)