Label: BENZOIN TINCTURE- benzoin resin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzoin

  • Purpose

    Protectant

  • Use

    Forms a coating over wound for protecting recurring canker sores

  • Warnings

    For external use only. Do not swallow. Do not exceed recommended dosage.

  • When using this product

    Children under 12 years of age should be supervised in the use of this product.

    Do not use for more than 7 days unless directed by a dentist or doctor.

  • Stop use and consult a dentist or doctor if

    sore mouth symptoms do not improve in 7 days. irritation, pain or redness persists or worsens. swelling, rash or fever develops.

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Adults and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more often than every 2 hours.

    Children under 6 months of age: Consult a dentiest or doctor.

  • Other information

    Flammable: Keep away from spark, heat or flame.

  • Inactive Ingredients

    Alcohol 77%, Aloe, Storax, Tolu Balsam

  • SM

    SMBenzz.jpg

  • INGREDIENTS AND APPEARANCE
    BENZOIN TINCTURE 
    benzoin resin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82645-924
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOIN RESIN (UNII: GK21SBA74R) (BENZOIN RESIN - UNII:GK21SBA74R) BENZOIN RESIN1000 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE (UNII: V5VD430YW9)  
    TOLU BALSAM (UNII: TD2LE91MBE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82645-924-9259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/12/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/01/2008
    Labeler - Pharma Nobis, LLC (118564114)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(82645-924) , analysis(82645-924) , pack(82645-924) , label(82645-924)
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