Label: CLOTRIMAZOLE solution

  • 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 March 30, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot infections and ringworm infections
    • relieve itching,burning, cracking, scaling and discomfort which can accompany these conditions
  • Warnings

    For external use only

    Do not use on children under 2 years of age unless directed by a doctor.

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

    KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wash affected area and dry thoroughly

    • apply to the affected area twice daily (morning and night) or as directed by your doctor

    • supervise children in the use of this product

    • for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily

    • for athlete’s foot and ringworm infections, use daily for 4 weeks

    • if condition persists longer, consult your doctor

  • Other information

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

    polyethylene glycol

  • Questions?

    1-855-763-8733

  • SPL UNCLASSIFIED SECTION

    Manufactured for

    The Podiatree Company, Holbrook, NY 11741

    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL - 10 mL Carton



    carton

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-018
    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:54633-018-101 in 1 CARTON03/30/2018
    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 finalpart333C03/30/2018
    Labeler - The Podiatree Company (078656000)
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