Label: CASTELLANI PAINT- phenol liquid 

  • Label RSS
  • NDC Code(s): 58980-820-10
  • Packager: Stratus Pharamceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Phenol 1.5%

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  • Purpose

    First Aid Antiseptic

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  • Uses

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

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  • Directions

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

    Store at controlled room temperature.

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  • Inactive Ingredients

    Acetone, Purified Water, Resorcinol, SD alcohol 40B (13%).

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  • Questions or Comments?

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

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  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Sonar Products, Inc.
    Carlstadt, NJ 07072

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  • 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
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  • INGREDIENTS AND APPEARANCE
    CASTELLANI PAINT 
    phenol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58980-820
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Phenol (Phenol) Phenol 15 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    ACETONE  
    RESORCINOL  
    ALCOHOL  
    Product Characteristics
    Color YELLOW (Clear to Yellow) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58980-820-10 1 in 1 BOX
    1 29.57 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part333A 04/01/2014
    Labeler - Stratus Pharamceuticals (789001641)
    Establishment
    Name Address ID/FEI Business Operations
    Sonar Products, Inc. 104283945 MANUFACTURE(58980-820)
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