Label: ANTIFUNGAL CREAM- antifungal cream

  • NDC Code(s): 68001-481-45, 68001-481-47, 68001-481-48
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 17, 2023

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

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

    carton

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

    1 oz tube

  • 2% Miconazole Nitrate Cream, USP Carton 0.5oz (14.2g)

    0.5 carton

  • 2% Miconazole Nitrate Cream, USP Tube 0.5oz (14.2g)

    0.5 tube

  • 2% Miconazole Nitrate Cream, USP Carton 1.5oz (42.5g)

    1.5 carton

  • 2% Miconazole Nitrate Cream, USP Tube 1.5oz (42.5g)

    1.5 tube

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL CREAM 
    antifungal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:68001-481-451 in 1 CARTON12/01/2020
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68001-481-471 in 1 CARTON12/01/2020
    242.5 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:68001-481-481 in 1 CARTON12/01/2020
    314.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00512/01/2020
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co., Ltd858030888manufacture(68001-481)