CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]

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  • CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]

CLOTRIMAZOLE SOLUTION [TARO PHARMACEUTICALS U.S.A., INC.]
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NDC 51672-2037-1
Set ID 13a14d3c-bfce-42b5-8463-4ec69e94774e
Category HUMAN OTC DRUG LABEL
Packager Taro Pharmaceuticals U.S.A., Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole USP, 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
    • effectively relieves
    • itching
    • cracking
    • burning
    • discomfort

    which can accompany these conditions

  • 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 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 best results, follow directions and continue treatment for length of time indicated. 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

    • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Inactive ingredient

    polyethylene glycol 400

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    Compare to the
    active ingredient
    in Lotrimin®AF*

    Cures Most Athlete's Foot

    Athlete's Foot
    Solution

    Clotrimazole Topical Solution USP,1%

    Antifungal

    • Relieves Itching & Burning
    • Greaseless,
      Nonstaining

    10 mL
    (⅓ fl oz)

    Principal Display Panel - 10 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2037
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    polyethylene glycol 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51672-2037-11 in 1 CARTON05/01/1996
    110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C05/01/1996
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2037)
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