MICONAZOLE- miconazole cream 
Kinray, Inc.

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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Antifungal

Active Ingredient

Miconazole Nitrate 2%

Warnings

For External Use Only

Do not use

When using this product 

Stop use and ask a doctor if

Uses

Indications and Usage

Other information.

Store at room temperature

Directions

Inactive Ingredients

Inactive Ingredients: Cetomacrogol 1000, cetostearyl alcohol, chlorocresol, liquid paraffin, propylene glycol, purified water, white soft paraffin.

Keep Out of Reach of Children

Principal Display Panel

Preferred Plus Pharmacy

Miconazole Nitrate Cream USP 2%

KR Miconazole.jpg

KR Miconazole

MICONAZOLE 
miconazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61715-050
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
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61715-050-0128.4 g in 1 TUBE; Type 0: Not a Combination Product03/22/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/21/2013
Labeler - Kinray, Inc. (012574513)
Registrant - Dynarex Corporation (008124539)

Revised: 6/2017
Document Id: 560c02ad-d329-4458-a761-c50d8b737d69
Set id: a44c3b24-dae2-4993-a49f-71e4eb63b231
Version: 10
Effective Time: 20170622
 
Kinray, Inc.