MICONAZOLE NITRATE CREAM USP, 2%- miconazole nitrate cream usp, 2% cream 
Cardinal Health

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CR-1232

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use

  • on children under 2 years of age unless directed by a doctor
  • for diaper rash

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 2 weeks when used for the treatment of jock itch
  • there is no improvement within 4 weeks when used for athlete's foot or ringworm

If swallowed, get medical help or contact a Poison Control Center (1800-222-1222) right away.

Directions

Other Information

Store at 15° -30°C (59° -86°F)

Inactive Ingredients

Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Disodium Hydrogen Phosphate Dihydrate, Light Liquid Paraffin, Macrogol Cetostearyl Ether, Propylene Glycol, Purified Water, Sodium Dihydrogen Phosphate Dihydrate, White Soft Paraffin

Questions

1-888-DYNAREX

Label

CR-1232 Primary Display Panel

MICONAZOLE NITRATE CREAM USP, 2% 
miconazole nitrate cream usp, 2% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0340
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0340-128.4 g in 1 TUBE; Type 0: Not a Combination Product07/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00507/30/2018
Labeler - Cardinal Health (063997360)
Registrant - Dynarex Corporation (008124539)

Revised: 1/2024
Document Id: 0f3c9fbd-a824-a4ce-e063-6294a90ac493
Set id: 776ca76a-a6cc-5238-e053-2a91aa0abfcb
Version: 8
Effective Time: 20240118
 
Cardinal Health