Label: CLOTRIMAZOLE- clotrimazole solution

  • NDC Code(s): 51672-2037-1
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • 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 April 22, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Clotrimazole USP, 1%

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  • Purpose

    Antifungal

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  • 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

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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 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.

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  • 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

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  • Other information

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

    polyethylene glycol 400

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2037
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole 1 g  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    polyethylene glycol 400 (UNII: B697894SGQ)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51672-2037-1 1 in 1 CARTON 05/01/1996
    1 10 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 05/01/1996
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-2037)
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