Label: CASTELLANI PAINT- phenol liquid

  • NDC Code(s): 58980-820-10
  • Packager: Stratus Pharamceuticals
  • 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 October 19, 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 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, Purified Water, Resorcinol, SD alcohol 40B (13%).

  • Questions or Comments?

    1-800-442-7882 or visit us at www.stratuspharmaceuticals.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Stratus Pharmaceuticals Inc.
    Miami, Florida 33186

  • PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Box

    NDC 58980-820-10

    Castellani Paint

    modified colorless phenol 1.5%

    STRATUS
    PHARMACEUTICALS INC

    FIRST AID ANTISEPTIC

    NET VOL. 1.0 FL OZ (29.57 mL)

    PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    CASTELLANI PAINT 
    phenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-820
    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
    Water (UNII: 059QF0KO0R)  
    ACETONE (UNII: 1364PS73AF)  
    RESORCINOL (UNII: YUL4LO94HK)  
    ALCOHOL (UNII: 3K9958V90M)  
    Product Characteristics
    ColorYELLOW (Clear to Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58980-820-101 in 1 BOX04/01/2014
    129.57 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A04/01/2014
    Labeler - Stratus Pharamceuticals (789001641)
    Establishment
    NameAddressID/FEIBusiness Operations
    TARMAC PRODUCTS INC059890491MANUFACTURE(58980-820) , LABEL(58980-820) , PACK(58980-820)
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