CLOTRIMAZOLE SOLUTION [THE PODIATREE COMPANY]

CLOTRIMAZOLE SOLUTION [THE PODIATREE COMPANY]
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NDC 54633-018-30
Set ID 79234400-0766-792c-e053-2a91aa0a6e6d
Category HUMAN OTC DRUG LABEL
Packager The Podiatree Company
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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

  • Inactive ingredient

    polyethylene glycol

  • Other information

    • Store at 20° to 25°C (68° to 77°F)
  • Questions?

    1-855-763-8733

  • SPL UNCLASSIFIED SECTION

    Manufactured for

    The Podiatree Company, Holbrook, NY 11741

    Made in U.S.A.

  • PRINCIPAL DISPLAY PANEL - 30 mL Carton

    artwork


  • 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:54633-018-301 in 1 CARTON10/26/2018
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/26/2018
    Labeler - The Podiatree Company (078656000)

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