ANTIFUNGAL CREAM- 2% miconazole nitrate cream cream 
Cardinal Health, 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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Antifungal Cream

Warnings

  • For external use only
  • Avoid contact with eyes
  • Keep out of reach of children
  • If swallowed, get medical help or contact Poison Control Center right away
  • For athlete's foot and ringworm, if irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a physician
  • For jock itch, if irritation occurs or there is no improvement within 2 weeks, discontinue use and consult a physician
  • Do not use on deep or puncture wounds, animal bites, serious burns, for diaper rash, on children younger tha 2 years of age.

Active Ingredients

Miconazole Nitrate 2%       Antifungal

Uses

A clinically effective treatment for:

  • most athlete's foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)

Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Uses

A clinically effective treatment for:

most athlete's foot (tinea pedis)jock itch (tinea cruris)ringworm (tinea corporis)

Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Directions

  • Glently cleanse the treatment area
  • Pat dry
  • Apply a thin layer of product to the affected area twice daily (morning and night) or as directed by a physician
  • For athlete's foot, pay close attention to area between toes, wear well-fitting ventilated shoes, and change shoes and socks at least once daily
  • Use daily for 4 weeks for treatment of athlete's foot and ringworm
  • Use daily for 2 weeks for treamnet of jock itch
  • If condition persists longer, consult a physician
  • This product is not effective on the scalp or nails

Directions

Glently cleanse the treatment areaPat dryApply a thin layer of product to the affected area twice daily (morning and night) or as directed by a physicianFor athlete's foot, pay close attention to area between toes, wear well-fitting ventilated shoes, and change shoes and socks at least once dailyUse daily for 4 weeks for treatment of athlete's foot and ringwormUse daily for 2 weeks for treamnet of jock itchIf condition persists longer, consult a physicianThis product is not effective on the scalp or nails

Other Information

Store between 15-30oC (59-86oF)

Keep out of reach of children

Keep out of reach of children

Inactive Ingredients

Allantoin, beeswax, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, disodium EDTA, fragrance, hydrogenated castor oil, isopropyl palmitate, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium chloride, zinc oxide

Artwork

Antifungal Cream Artwork

ANTIFUNGAL CREAM 
2% miconazole nitrate cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 1000 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIMETHICONE 1000 (UNII: MCU2324216)  
CETYL DIMETHICONE 45 (UNII: IK315POC44)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WHITE WAX (UNII: 7G1J5DA97F)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
CUCUMBER FRUIT OIL (UNII: R81Y52NPCT)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63517-009-04120 g in 1 TUBE; Type 0: Not a Combination Product01/01/201511/14/2022
2NDC:63517-009-055 g in 1 PACKET; Type 0: Not a Combination Product01/01/201511/14/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201511/14/2022
Labeler - Cardinal Health, Inc. (961027315)

Revised: 11/2022
 
Cardinal Health, Inc.