Label: BENZOIN 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 June 19, 2020

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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:0395-9107
    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:0395-9107-9259 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 not finalpart35601/01/2008
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884manufacture(0395-9107) , analysis(0395-9107) , pack(0395-9107) , label(0395-9107)
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