Label: ANTIFUNGAL CREAM- antifungal cream

  • NDC Code(s): 68001-475-45, 68001-475-46, 68001-475-47
  • Packager: BluePoint Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 17, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1 %

  • Purpose

    Antifungal

  • Uses

    • For the treatment of 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 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 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.

  • Keep Out Of Reach Of Children

    if swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean the affected area and dry thoroughly. Apply a thin layer of cream 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.
  • DOSAGE & ADMINISTRATION

    • For athletes 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

    • 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 room temperature
    • Preserve in tight containers
    • See crimp of tube or carton for Lot Number and Expiry Date
  • INACTIVE INGREDIENTS

    Inactive Ingredients: Cetostearyl Alcohol, Methylparaben, Mineral Oil, Polyoxyl 20 Cetostearyl Ether,

    Propylene Glycol, Propylparaben, Purified water, White petrolatum

  • Questions?

    Contact 1-800-707-4621

    Manufactured in India by:

    Gopaldas Visram & 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

    Rev 09/2021

  • PRINCIPAL DISPLAY PANEL

    Clotrimazole 1% 0.5oz 68001-475-45

    0.5 tube0.5 carton

  • Principal Display Panel

    1 oz carton Clotrimazole 1% 1oz 68001-475-47

    1 oz tube

  • INGREDIENTS AND APPEARANCE
    ANTIFUNGAL CREAM 
    antifungal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68001-475
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68001-475-471 in 1 CARTON11/25/2020
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68001-475-461 in 1 CARTON11/25/202006/14/2021
    215 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:68001-475-451 in 1 CARTON11/25/2020
    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 DrugM00511/25/2020
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co., Ltd858030888manufacture(68001-475)
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