ANTI-FUNGAL- miconazole nitrate cream 
Universal Distribution Center 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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Anti-Fungal Cream

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

For external use only.

When using this product avoid contact with eyes.

Stop using this product and ask a doctor

Keep this and all drugs out of reach of children.

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

Directions

Other information

Inactive Ingredients

Purified water, cetostearyl alcohol, cetomacrogol-1000, mineral oil, petrolatum, propyleneglycol, sodium phosphate, chlorocresol.

PRINCIPAL DISPLAY PANEL

Anti-Fungal Cream

NET WT 0.5 OZ (14 g)

label

ANTI-FUNGAL 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-061
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE0.02 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
CHLOROCRESOL (UNII: 36W53O7109)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-061-011 in 1 BOX12/09/2020
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/09/2020
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
Establishment
NameAddressID/FEIBusiness Operations
Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-061)

Revised: 12/2020
Document Id: b60871ac-cbda-e21e-e053-2995a90ad8ca
Set id: 91a8d893-c51f-42de-8e7f-be496507fe7c
Version: 1
Effective Time: 20201209
 
Universal Distribution Center LLC