Label: BENZOIN swab

  • NDC Code(s): 46414-8888-2
  • Packager: James Alexander Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 27, 2020

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  • Drug Facts

  • Active Ingredients (each swab)

    Benzoin 10%}

    Aloe 2%} 

    Storax 8%}

    Tolu Balsam 4%}

  • Purpose

    Topical bandage adhesive

  • Uses

    An adhesive to hold bandages in place.

  • Warnings

    For external use only.

    Allergy alert if you have had a history of contact dermatitis with benzoin compounds.

    When using this product avoid getting in the wound.

    Stop and ask a doctor if a rash develops.

    Flammable liquid Keep away from heat, sparks and open flame.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Clean and dry skin around the wound. • Gently squeeze vial to crush inner ampoule. • Allow tincture to saturate the tip of the vial, and carefully apply a thin film of the tincture to the skin on each side of the wound. • Allow tincture to dry (30 –40 seconds) before applying bandages.

  • Other Information

    Store at room temperature.

  • Inactive Ingredients

    Alcohol

  • Questions?

    Call 1-908-362-9266, Monday through Friday, 9:00am – 5:00pm e.s.t.

  • SPL UNCLASSIFIED SECTION

    DISPENSING SOLUTIONS®


    JAMES ALEXANDER CORPORATION
    Blairstown, NJ• (908) 362-9266
    Product information and MSDS available on-line at:
    www.james-alexander.com

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BENZOIN 
    benzoin swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46414-8888
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOIN, (+/-)- (UNII: L7J6A1NE81) (BENZOIN, (+/-) - UNII:L7J6A1NE81) BENZOIN, (+/-)-0.6 g  in 0.6 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE.12 g  in 0.6 mL
    TOLU BALSAM (UNII: TD2LE91MBE) (BALSAM PERU - UNII:8P5F881OCY) TOLU BALSAM.24 g  in 0.6 mL
    LIQUIDAMBAR STYRACIFLUA RESIN (UNII: P41GWD11CX) (LIQUIDAMBAR STYRACIFLUA RESIN - UNII:P41GWD11CX) LIQUIDAMBAR STYRACIFLUA RESIN.48 g  in 0.6 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46414-8888-260 mL in 1 BOX; Type 0: Not a Combination Product10/25/197602/28/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/25/197602/28/2025
    Labeler - James Alexander Corporation (040756421)
    Registrant - James Alexander Corporation (040756421)
    Establishment
    NameAddressID/FEIBusiness Operations
    James Alexander Corporation040756421manufacture(46414-8888)
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