Label: ANTIFUNGAL CREAM- 2% miconazole nitrate cream cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 7, 2017

If you are a consumer or patient please visit this version.

  • 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.
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  • Active Ingredients

    Miconazole Nitrate 2%       Antifungal

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  • 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

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  • 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

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  • 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
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  • 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

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  • Other Information

    Store between 15-30oC (59-86oF)

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  • Keep out of reach of children

    Keep out of reach of children

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  • 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

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  • labeling
  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL CREAM 
    2% miconazole nitrate cream cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63517-009
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g  in 1000 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color white Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63517-009-04 120 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2015
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 01/01/2015
    Labeler - Cardinal Health (097537435)
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