CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]

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CLOTRIMAZOLE CREAM [H.J. HARKINS COMPANY, INC.]
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NDC 52959-088-03, 52959-088-05
Set ID 8fcf70e8-70e2-4b41-99c0-a351b2c3a2a0
Category HUMAN OTC DRUG LABEL
Packager H.J. Harkins Company, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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

    Repcaked by:
    H.J. Harkins Company, Inc.
    U.S.A., Inc.
    Nipomo, CA 93444

  • 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

    Principal Display Panel - 15 g Carton
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-088(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:52959-088-0315 g in 1 TUBE
    2NDC:52959-088-0530 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C06/01/1995
    Labeler - H.J. Harkins Company, Inc. (147681894)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE
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