Label: NEW SKIN BANDAGE- benzethonium chloride liquid

  • NDC Code(s): 16864-440-01, 16864-440-02, 16864-440-03
  • Packager: Advantice Health, LLC
  • 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 January 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzethonium chloride 0.2%

  • Purpose

    First aid antiseptic

  • Use

    first aid to help prevent bacterial contamination in minor cuts and scrapes

  • Warnings

    For external use only

    Flammable

    keep away from fire or flame

    Do not use

    • in the eyes
    • over large areas of the body
    • longer than one week unless directed by a doctor
    • on infected areas or wounds that are draining
    • with other first aid products such as lotions and creams
    • over sutures
    • on mucous membranes

    Ask a doctor before use if you have

    • deep or puncture wounds
    • deep cuts
    • animal bites
    • serious bleeding
    • diabetes
    • poor circulation
    • serious burns

    When using this product

    • do not store at temperatures above 120°F
    • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

    Stop use and ask a doctor if

    • condition persists or gets worse
    • infection occurs

    Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

  • Directions

    • clean affected area
    • apply small amount on the area 1–3 times daily
    • let dry
    • a second coating may be applied for extra protection
    • to remove, apply more New-Skin® Liquid Bandage and quickly wipe off
  • Other information

    • store at 20-25°C (68-77°F), away from heat
    • may temporarily sting upon application
    • keep carton for full drug facts
    • do not allow to come into contact with floors, countertops or other finished surfaces – will stain
  • Inactive ingredients

    amyl acetate, butyl acetate, camphor, ethyl acetate, nitrocellulose, SD alcohol 3-C (7.2% v/v)

  • Questions?

    1-800-345-0032

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Advantice Health, LLC
    Cedar Knolls, NJ 07927

  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box

    new-
    Skin®

    Benzethonium Chloride 0.2%/First Aid Antiseptic

    LIQUID BANDAGE

    Brush

    ALL-IN-ONE PROTECTION

    Prevents
    Infection

    Seals Out Water,
    Dirt & Germs

    Helps
    Heal Cuts

    #1
    pharmacist
    recommended

    Works
    Where
    Bandages
    Can't

    1.0 FL OZ (30 mL)

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    NEW SKIN BANDAGE 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-440
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride1.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    ACETONE (UNII: 1364PS73AF)  
    BUTYL ACETATE (UNII: 464P5N1905)  
    AMYL ACETATE (UNII: 92Q24NH7AS)  
    ALCOHOL (UNII: 3K9958V90M)  
    PYROXYLIN (UNII: KYR8BR2X6O)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-440-021 in 1 BOX03/01/2011
    110 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:16864-440-011 in 1 BOX03/01/2011
    230 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    3NDC:16864-440-031 in 1 BOX03/01/2011
    313 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A03/01/2011
    Labeler - Advantice Health, LLC (192527062)
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