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

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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CR-1232

Active Ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

  • For the treatment of most athlete's foot, tinea pedis, jock itch, tinea crusis, ringworm, tinea corporis
  • Relieves itching, scaling, burning, discomfort and chafing associated with jock itch or itching, burning feet

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

  • Clean the affected area and dry thoroughly
  • Apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • For athlete's foot and ringworm, use daily for 4 weeks
  • For jock itch, use daily for 2 weeks
  • If condition persists longer, consult a doctor
  • This product is not effective on the scalp or nails

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 finalpart333C07/30/2018
Labeler - Cardinal Health (063997360)
Registrant - Dynarex Corporation (008124539)

Revised: 11/2022
Document Id: edc1fb09-9f35-8bdf-e053-2995a90a7977
Set id: 776ca76a-a6cc-5238-e053-2a91aa0abfcb
Version: 7
Effective Time: 20221118
 
Cardinal Health