Label: CASTELLANI PAINT 1.5%- phenol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 20, 2017

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  • 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

  • PRINCIPAL DISPLAY PANEL

    product label
  • INGREDIENTS AND APPEARANCE
    CASTELLANI PAINT 1.5% 
    phenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-612
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL15 mg  in 1 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:54633-612-0129.57 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2013
    Labeler - The Podiatree Company (078656000)
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