Label: NEW SKIN BANDAGE- benzethonium chloride spray

  • NDC Code(s): 16864-450-01
  • Packager: Advantice Health, LLC.
  • Category: HUMAN OTC DRUG LABEL

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 get in eyes
    • do not store at temperatures above 120° F
    • do not puncture or incinerate; contents under pressure
    • 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
    • shake well
    • spray a 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 Spray and quickly wipe off
    • New-Skin® may at times form a thin covering over the spray hole. If valve doesn't spray, simply scratch across spray hole with fingernail
  • Other information

    • store at 20-25°C (68-77°F), away from heat
    • may temporarily sting upon application
    • do not allow to come into contact with floors, counter tops or other finished surfaces - will stain
  • Inactive ingredients

    acetone, amyl acetate, butyl acetate, camphor, ethyl acetate, isobutane, nitrocellulose, propane, SD alcohol 3-C (4.9% v/v)

  • Questions?

    1-800-345-0032
    www.NewSkinProducts.com

  • SPL UNCLASSIFIED SECTION

    Distributed by Advantice Health, LLC
    Cedar Knolls, NJ 07927

  • PRINCIPAL DISPLAY PANEL - 28.5 g Canister Box

    new-
    skin®
    Benzethonium Chloride 0.2%/First Aid Antiseptic
    LIQUID BANDAGE
    SPRAY

    ALL-IN-ONE
    PROTECTION

    Prevents Infection

    Seals Out Water,
    Dirt & Germs

    Helps Heal Cuts

    Protects Wounds,
    Blisters & Calluses

    #1
    pharmacist
    recommended

    NET WT
    1 OZ (28.5 g)

    Works
    Where
    Bandages
    Can't

    PRINCIPAL DISPLAY PANEL - 28.5 g Canister Box
  • INGREDIENTS AND APPEARANCE
    NEW SKIN BANDAGE 
    benzethonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16864-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride60 mg  in 1 g
    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)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16864-450-011 in 1 BOX03/01/2011
    128.5 g in 1 CANISTER; 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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