Label: CASTELLANI PAINT- 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 May 15, 2014

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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.
    •
    care should be taken to avoid spilling and guard against staining. Castellani Paint Modified 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, basic violet 14 (basic fuchsine), resorcinol, SD alcohol 40B (13%), water.

  • Questions or Comments?

    1-800-PEDiNOL (733-4665) or visit us at www.pedinol.com

  • PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Label


    PEDiNOL™

    castellani paint

    modified with color

    phenol 1.5%

    first aid antiseptic

    net vol. 1 fl. oz. (29.57 ml)

    Castellani Paint Bottle Label 29.57 ml


    Distributed by:

    Physicians Total Care, Inc.

    Tulsa, OK  74146

    NDC 54868-0127-0

    package label

  • INGREDIENTS AND APPEARANCE
    CASTELLANI PAINT 
    phenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0127(NDC:0884-2893)
    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)  
    ROSANILINE HYDROCHLORIDE (UNII: 8UUC89LHB2)  
    RESORCINOL (UNII: YUL4LO94HK)  
    ALCOHOL (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-0127-029.57 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/15/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-0127)
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