Label: COMPOUND BENZOIN TINCTURE- tincture of benzoin 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, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients: Aloe, Benzoin, Storax, Tolu Balsam, Ethanol

  • PURPOSE

    Purpose: Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Warnings: Keep out of reach of children.  Ingestion will result in severe gastrointestinal distress, unconsciousness and death.  If ingested induce vomiting if the victim is conscious.  Contact a poison control center immediately.

  • INDICATIONS & USAGE

    Directions: Apply to affected area for first-aid treatment of minor cuts and abrasions.  Discontinue use and get medical aid if redness, irritation or infection develops.  In case of deep or puncture wounds consult a physician.

  • WARNINGS

    Warnings: Keep out of reach of children.  Ingestion will result in a severe gastrointestinal distress, unconsciousness and death.  If ingested induce vomiting if victim is conscious.  Contact a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions: Apply to affected area for first-aid treatment of minor cuts and abrasions.  Discontinue use and get medical aid if redness, irritation or infection develops.  In case of deep or puncture wounds consult a physician.

  • INACTIVE INGREDIENT

    Enter section text here

  • PRINCIPAL DISPLAY PANEL

    benzoinlabel.jpg

    Compound Benzoin Tincture Label

  • INGREDIENTS AND APPEARANCE
    COMPOUND BENZOIN TINCTURE 
    tincture of benzoin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12745-109-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/1954
    2NDC:12745-109-02118 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/15/1954
    3NDC:12745-109-03118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/15/1954
    4NDC:12745-109-04473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1954
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/15/1954
    Labeler - Medical Chemical Corporation (008496861)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Chemical Corporation008496861manufacture(12745-109)
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