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
  • 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 November 3, 2021

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)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    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 finalpart333C12/01/2020
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co., Ltd858030888manufacture(68001-481)