ANTI-FUNGAL- miconazole nitrate cream 
Universal Distribution Center LLC

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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 DrugM00512/09/2020
Labeler - Universal Distribution Center LLC (019180459)

Revised: 12/2024
Document Id: abef15f7-3144-49c0-8131-138668561d54
Set id: 91a8d893-c51f-42de-8e7f-be496507fe7c
Version: 2
Effective Time: 20241203
 
Universal Distribution Center LLC