Label: MICONAZOLE NITRATE CREAM USP, 2% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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