FORTINIA ID (PHENOL) LIQUID [THE PODIATREE COMPANY]

FORTINIA ID (PHENOL) LIQUID [THE PODIATREE COMPANY]
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NDC 54633-216-15
Set ID 60c88eb7-22fe-4881-e053-2a91aa0a70ce
Category HUMAN OTC DRUG LABEL
Packager The Podiatree Company
Generic Name
Product Class
Product Number
Application Number PART333A
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Phenol 1.5%

  • Purpose

    First Aid Antiseptic

  • Uses

    • First aid antiseptic to help protect against skin infection in minor cuts, scrapes or burns
  • Warnings

    For external use only

    Do not use

    • in eyes
    • with bandages
    • on large areas of the body
    • longer than one week unless directed by a doctor
    • stop use and consult a doctor if condition persists
    • in case of deep puncture wounds, animal bites, or serious burns, consult a doctor
    • if known to be sensitive to any ingredients in this product

    Stop use and ask a doctor or pharmacist if skin irritation or sensitivity develops or increases or if the condition persists or gets worse.

    When using this product

    • Check skin for sensitivity to phenol prior to application
    • Use caution when applying as this product will stain skin and clothing

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    • clean the affected area
    • apply a small amount on the area one to three times daily
  • Other Information

    Store at controlled room temperature

  • Inactive Ingredients

    Acetone, resorcinol, SD alcohol (13%), water

  • Questions or Suggestions?

    1.855.763.8733 or visit us at www.thepodiatreecompany.com. Our commitment to you is 100% satisfaction. If you are not

    completely satisfied, please contact us directly for a full refund.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FORTINIA ID 
    phenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    RESORCINOL (UNII: YUL4LO94HK)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54633-216-1514.8 mL in 1 BOTTLE; Type 0: Not a Combination Product01/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/03/2017
    Labeler - The Podiatree Company (078656000)

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