Label: REXALL MAXIMUM STRENGTH- benzocaine liquid

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

Drug Label Information

Updated March 7, 2024

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzocaine 20.0% ..................................Purpose: Oral pain reliever

  • Uses

    Temporarily relieves pain associated with the following mouth irritations  toothache sore gums canker sores braces minor dental procedures

  • WARNINGS

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other “caine” anesthetics

    When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage
    • Do not use more than directed for more than 7 days unless directed by a dentist or doctor.

    Stop use and ask a doctor if sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, irritation, pain or redness persists or worsens swelling rash or fever developes

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older:

    • apply to affect4ed area using applicator tip
    • use up to 4 times daily or as directed by a dentist or doctor. 
    • Children under 12 years of age should be supervised in the use of this product.

    Children under 2 years of age: ask a dentist or doctor.

  • Other Information

    Do not use if package has been opened

    Store at 20-25°C (68-77°F)

  • Inactive ingredients

    Benzyl Alcohol, D&C Yellow 10, FD&C Blue 1, FD&C Red 40, FD&C Yellow 5, Methylparaben, Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

  • DOSAGE & ADMINISTRATION

    Adults and children 2 years of age and older:
    apply to affect4ed area using applicator tip
    use up to 4 times daily or as directed by a dentist or doctor.
    Children under 12 years of age should be supervised in the use of this product.
    Children under 2 years of age: ask a dentist or doctor.

  • PRINCIPAL DISPLAY PANEL

    Card R3

  • INGREDIENTS AND APPEARANCE
    REXALL  MAXIMUM STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-346
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colororange (dark orange/red to sl brown) Score    
    ShapeSize
    FlavorMINT (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-346-791 in 1 CARTON02/01/2023
    114.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/01/2015
    Labeler - Rexall (068331990)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    HK KOLMAR CANADA, INC243501959manufacture(55910-346) , pack(55910-346)