Label: BENZOIN COMPOUND TINCTURE- benzoin resin liquid

  • 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 17, 2018

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  • Active Ingredient

    Tincture Benzoin compound

  • Intended Use

    Antiseptic preparation maintains skin
    integrity and protects skin from adhesive and harsh body
    fluids. Forms a fine coating over skin, abrasions, wounds
    and oral lesions.

  • Directions

    For adults and supervised children 2 years and older:
    Dry affected area of skin or oral mucosa. Apply with a cotton
    swab or gauze every 3-4 hours or as directed by your physician.

  • Warnings

    For external use only.
    Do not apply to or near eyes. Do not swallow. In case of accidental
    ingestion seek professional assistance or contact poison control
    center immediately.
    FLAMMABLE: Keep away from sparks, heat and flames.
    When using this product:
    Discontinue use and consult a physician if irritation persists,
    worsens or if swelling or rash develops. Do not use for more
    than 10 days unless directed by your physician.

  • DOSAGE & ADMINISTRATION

    Apply with a cotton
    swab or gauze every 3-4 hours

  • INACTIVE INGREDIENT

    Benzoin Resin

  • STORAGE AND HANDLING

    To be stored at room temperature 15-30°C (59-86°F). Avoid exposure
    to direct sunlight or heat.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • PRINCIPAL DISPLAY PANEL

    1OZ

    2OZ

    4OZ

  • INGREDIENTS AND APPEARANCE
    BENZOIN COMPOUND TINCTURE 
    benzoin resin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE (UNII: V5VD430YW9)  
    LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93)  
    TOLU BALSAM (UNII: TD2LE91MBE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-100-0258 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
    2NDC:54162-100-0129 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
    3NDC:54162-100-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/31/2015
    Labeler - Geritrex LLC (112796248)
    Registrant - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Frutarom237870915manufacture(54162-100)
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