CAREALL MICONAZOLE NITRATE- miconazole nitrate cream 
New World Imports, 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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Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Keep out of Reach of Children

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 avoide contact with eyes

Stop use and ask doctor if

Directions

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Purified Water, White Petrolatum

AFMC1 Carton

CAREALL MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-078
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51824-078-0128 g in 1 TUBE; Type 0: Not a Combination Product12/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/01/2020
Labeler - New World Imports, Inc (075372276)

Revised: 10/2022
Document Id: 2dad4db4-47a4-4ca2-88a0-2c0cb9285f89
Set id: bed775be-8bcb-44c2-9b9f-8bb25b4b2453
Version: 3
Effective Time: 20221020
 
New World Imports, Inc