MICONAZOLE NITRATE ANTIFUNGAL POWDER- miconazole nitrate antifungal powder powder 
Marlex Pharmaceuticals, Inc.

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Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Warnings

Do not use

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control center right away.

Directions

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

Other Information

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

label

MICONAZOLE NITRATE ANTIFUNGAL POWDER 
miconazole nitrate antifungal powder powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10135-720
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
IMIDUREA (UNII: M629807ATL)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
ALLANTOIN (UNII: 344S277G0Z)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10135-720-8585 g in 1 BOTTLE; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00505/01/2022
Labeler - Marlex Pharmaceuticals, Inc. (782540215)

Revised: 11/2023
Document Id: 09bb906e-2e08-8afb-e063-6294a90af376
Set id: de4f703c-39e9-855e-e053-2a95a90a6ea9
Version: 2
Effective Time: 20231109
 
Marlex Pharmaceuticals, Inc.