MICONAZOLE NITRATE- miconazole nitrate cream 
NuCare Pharmaceuticals, 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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Miconazole Nitrate Cream - Antifungal Cream

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

Stop use and ask a doctor if

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.

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MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66267-960(NDC:0472-0735)
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:66267-960-3030 g in 1 TUBE; Type 0: Not a Combination Product07/24/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/01/2007
Labeler - NuCare Pharmaceuticals, Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals, Inc.010632300relabel(66267-960)

Revised: 5/2018
Document Id: 6d6013a4-cca7-475b-e053-2a91aa0a92e5
Set id: 5516f9d6-cf6b-58a2-e054-00144ff8d46c
Version: 2
Effective Time: 20180529
 
NuCare Pharmaceuticals, Inc.