Label: ANTIFUNGAL CREAM- antifungal cream

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

Drug Label Information

Updated May 1, 2024

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

  • Drug Facts

  • Active ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Uses

    For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), Ringworm (tinea corporis).
    For the treatment of superficial skin infections caused by yeast (Candida Albicans)
    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
  • 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 and ringworm
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Centre right away.

  • Directions

    Clean the affected area and dry thoroughly.
    Apply a thin layer of the product 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 scalp or nails.
  • Other information

    Do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal.
    Store at controlled room temperature.
    Preserve in tight container.
    See crimp of tube or carton for Lot Number and expiry date.
  • Inactive ingredients

    Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether 20, Propylene Glycol, Purified Water, Sodium Phosphate Dibasic Dihydrate, Sodium Phosphate Monobasic Dihydrate, White Petrolatum.

  • Questions?

    Contact 1-800-707-4621

    Manufactured in India by:

    Gopaldas Visram and Company Limited.

    Plot No. A327, T.T.C. Indl. Area, M.I.D.C.

    Mahape, Navi Mumbai - 400710 Mfg. Lic. No.: KD/739

    For BluePoint Laboratories

    Relabeled By: Preferred Pharmaceuticals Inc.

    NDC 68788-8645-2

  • 2% Miconazole Nitrate Cream, USP Carton 1oz (28.4g)

    Miconazole Nitrate 2% Cream
  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL CREAM 
    antifungal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8645(NDC:68001-481)
    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
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8645-21 in 1 CARTON05/01/2024
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00505/01/2024
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8645)