Label: CLOTRIMAZOLE solution

  • NDC Code(s): 0536-1443-70
  • Packager: Rugby Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 27, 2024

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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 ingredients

    polyethylene glycol 400

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    RUGBY ®LABORATORIES
    Indianapolis, IN 46268

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    Rugby ®

    NDC 0536-1443-70
    Compare to the
    active ingredient in
    Lotrimin ®AF*
    Clotrimazole Antifungal

    Clotrimazole
    Topical Solution
    USP, 1%
    Antifungal

    Cures Most
    Athlete's Foot

    • 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:0536-1443
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1443-701 in 1 CARTON11/21/2024
    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 DrugM00511/21/2024
    Labeler - Rugby Laboratories, Inc. (079246066)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295manufacture(0536-1443)
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