Label: CLOTRIMAZOLE cream

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

Drug Label Information

Updated January 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    •
    cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
    •
    for effective relief of
    •
    itching
    •
    scaling
    •
    cracking
    •
    burning
    •
    redness
    •
    soreness
    •
    irritation
    •
    discomfort
  • Warnings

    For external use only

    Ask a doctor before use

    •
    on children under 2 years of age

    When using this product

    •
    avoid contact with eyes

    Stop use and ask a doctor if

    •
    irritation occurs
    •
    there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    This product is not effective on the scalp or nails.

    For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

    •
    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; change shoes and socks at least once daily

  • Other information

    •
    To open: unscrew cap, use the pointed end of cap to puncture seal.
    •
    store between 2°- 30°C (36° - 86°F)
    •
    see carton or tube crimp for lot number and expiration date
  • Inactive ingredients

    benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Taro Pharmaceuticals
    U.S.A., Inc.
    Hawthorne, NY 10532

    Relabeled by:
    Proficient Rx LP
    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL - 15 g Carton

    Cures Most Athlete's Foot

    Athlete's Foot
    Cream
    Clotrimazole Cream USP,1%
    Antifungal Cream

    Antifungal Cream

    NET WT (1/2 oz) 15 g

    63187-501-15
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-501(NDC:51672-2002)
    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
    benzyl alcohol (UNII: LKG8494WBH)  
    cetostearyl alcohol (UNII: 2DMT128M1S)  
    cetyl esters wax (UNII: D072FFP9GU)  
    polysorbate 60 (UNII: CAL22UVI4M)  
    water (UNII: 059QF0KO0R)  
    sorbitan monostearate (UNII: NVZ4I0H58X)  
    Product Characteristics
    ColorWHITE (Smooth) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-501-151 in 1 CARTON02/02/2015
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:63187-501-301 in 1 CARTON02/02/2015
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/01/1995
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(63187-501)
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