MICONAZOLE NITRATE ANTIFUNGAL POWDER powder

Miconazole Nitrate Antifungal Powder by

Drug Labeling and Warnings

Miconazole Nitrate Antifungal Powder by is a Otc medication manufactured, distributed, or labeled by Marlex Pharmaceuticals, Inc., Davion, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

• For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• For the treatment of most superficial skin infections caused by yeast (candida albicans)
• Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort 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
• avoid contact with the eyes
• for athlete's foot and ringworm- if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor
• for jock itch - if irritation occurs or if there is no improvement within 2 weeks, discontinue use and consult a doctor

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 layer of power over affected area twice a day (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 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 condition persists longer, consult a doctor
• This product is not effective on the scalp or nails.

Other Information

• Protect from freezing. Avoid excessive heat.
• Do not use if package is damaged

Inactive ingredients

Allantoin, Chloroxylenol, fragrance, Imidazolidinyl Urea, Microcrystalline Cellulose, Tricalcium Phosphate, Corn starch.

Manufactured For/ Distributed By:

Marlex Pharmaceuticals, Inc.

New Castle, DE 19720

Rev. 04/22 DV

Principal Display Panel

INGREDIENTS AND APPEARANCE

MICONAZOLE NITRATE ANTIFUNGAL POWDER 
miconazole nitrate antifungal powder powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10135-720
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHLOROXYLENOL (UNII: 0F32U78V2Q)
IMIDUREA (UNII: M629807ATL)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)
ALLANTOIN (UNII: 344S277G0Z)
STARCH, CORN (UNII: O8232NY3SJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10135-720-85	85 g in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	05/01/2022

Labeler - Marlex Pharmaceuticals, Inc. (782540215)

Establishment
Name	Address	ID/FEI	Business Operations
Davion, Inc.		079536689	manufacture(10135-720)