Label: BENZOIN TINCTURE- benzoin resin liquid

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

Drug Label Information

Updated December 17, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzoin Tincture

  • Purpose

    Oral mucosal protectant

  • Use

    Forms a coating over wound for protecting recurring canker sores

  • Warnings

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

  • When using this product

    do not use in the eyes

    do not use this product for longer than 1 week unless directed by a dentist or doctor

  • Stop use and consult a dentist or doctor if

    • the condition persists or gets worse
    • symptoms do not improve in 7 days.
    • pain, irritation, swelling, redness, rash or fever develop
  • Keep out of the reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immeditely. (1-800-222-1222)

  • Directions

    Adult and children 6 months of age and older: Dry the affected area. Saturate a cotton applicator with medication and apply undiluted to the affected area not more than every 2 hours.

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

  • Inactive Ingredients

    Alcohol 79%, Aloe, Stoax, Tolu Balsam.

  • Questions?

    Call 833-358-6431

  • Principal Display Panel

    FT Benzoin Tincture

  • INGREDIENTS AND APPEARANCE
    BENZOIN TINCTURE 
    benzoin resin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1200
    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:70677-1200-159 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/17/2024
    Labeler - 116956644 (116956644)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(70677-1200) , analysis(70677-1200) , pack(70677-1200) , label(70677-1200)
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