Label: BENZOIN- 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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 5, 2019

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  • Drug Facts
  • Active Ingredients (each swab)

    Benzoin 10%}

    Aloe 2%} 

    Storax 8%}

    Tolu Balsam 4%}

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  • Purpose

    Topical bandage adhesive

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  • Uses

    An adhesive to hold bandages in place.

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  • 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.

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  • 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.

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  • 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.

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  • Other Information

    Store at room temperature.

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  • Inactive Ingredients

    Alcohol

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  • Questions?

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

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  • 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

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    BENZOIN 
    benzoin swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46414-8888
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    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 Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46414-8888-2 60 mL in 1 BOX; Type 0: Not a Combination Product 10/25/1976
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 10/25/1976
    Labeler - James Alexander Corporation (040756421)
    Registrant - James Alexander Corporation (040756421)
    Establishment
    Name Address ID/FEI Business Operations
    James Alexander Corporation 040756421 manufacture(46414-8888)
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