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
  • 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 October 13, 2021

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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 finalpart333C11/25/2020
    Labeler - BluePoint Laboratories (985523874)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopaldas Visram & Co., Ltd858030888manufacture(68001-475)
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