Label: CVS PHARMACY  ITCH RELIEF ANTIFUNGAL- clotrimazole cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Clotrimazole 1%

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  • Purpose

    Antifungal

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  • Uses

    • cures most jock itch (tinea cruris)
    • for effective relief of
      • itching
      • scaling
      • cracking
      • burning
      • redness
      • soreness
      • irritation
      • discomfort
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  • 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 2 weeks (for jock itch)

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

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  • Directions

    This product is not effective on the scalp or nails.

    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
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  • 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
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  • Inactive ingredients

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

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  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

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  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    CVS®
    pharmacy

    Compare to the active
    ingredient in Lotrimin® AF*

    ITCH RELIEF
    ANTIFUNGAL CREAM

    CVS PHARMACIST
    RECOMMENDED

    CLOTRIMAZOLE CREAM USP, 1%
    NET WT 0.5 OZ (15 g)

    Principal Display Panel - 15 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY   ITCH RELIEF ANTIFUNGAL
    clotrimazole cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-510
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clotrimazole (Clotrimazole) Clotrimazole 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    benzyl alcohol  
    cetostearyl alcohol  
    cetyl esters wax  
    octyldodecanol  
    polysorbate 60  
    water  
    sorbitan monostearate  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-510-01 1 in 1 CARTON
    1 15 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 08/31/1993
    Labeler - CVS Pharmacy (062312574)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(59779-510)
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