MICONAZOLE- miconazole nitrate cream 
Chain Drug Consortium, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Miconazole Nitrate Cream, USP

Drug Facts

Active ingredient

Miconazole nitrate, USP 2%

Purpose

Antifungal

Uses

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 use and ask a doctor if

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

Other information

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Principal Display Panel

Premier Value®

COMPARE TO THE ACTIVE INGREDIENT IN MICATIN® ANTIFUNGAL CREAM*

Miconazole Nitrate Cream, USP 2%
ANTIFUNGAL CREAM

Cures Most Athlete’s Foot, Jock Itch & Ringworm. 

Soothes Itching, Scaling, Cracking, and Burning 

NET WT 1 OZ (28g)

1 oz carton
MICONAZOLE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-291
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
MINERAL OIL (UNII: T5L8T28FGP)  
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-291-011 in 1 CARTON05/15/2009
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C05/15/2009
Labeler - Chain Drug Consortium, LLC (101668460)

Revised: 11/2019
Document Id: 20396988-a379-4708-9bd9-f9c3c727c7e0
Set id: 246be926-79ea-4e0c-a3ef-2aa7fc3a52bf
Version: 9
Effective Time: 20191119
 
Chain Drug Consortium, LLC