Label: TOPCARE MAXIMUM STRENGTH- benzocaine liquid

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

Drug Label Information

Updated March 7, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzocaine 20.0% (w/w)

  • PURPOSE

    Purpose

    Oral anesthetic

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves pain associated with the following mouth and gum irritations:

    • toothache
    • sore gums
    • canker sores
    • braces
    • minor dental procedures
  • WARNINGS

    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 for more than 7 days unless directed by a dentist or doctor

    Stop use and ask doctor or dentist 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children 2 years of age and older:
    • apply to affected 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: consult a dentist or doctor
  • STORAGE AND HANDLING

    Other information

    • do not use if package has been opened
    • store at 20 - 25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients Benzyl Alcohol, D&C Yellow no. 10, FD&C Blue no. 1, FD&C Red no. 40, Methylparaben, Natural and Artifical Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC

    ELK GROVE VILLAGE, IL 60007

    QUESTIONS?

    1-888-423-0139

    topcare@topco.com

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL

    Card R4

  • INGREDIENTS AND APPEARANCE
    TOPCARE  MAXIMUM STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-443
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorred (dark orange/red to sl brown) Score    
    ShapeSize
    FlavorMINT (N&A Mint Flavor 619179) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-443-581 in 1 BLISTER PACK10/01/2014
    114.17 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/01/2014
    Labeler - Topco Associates LLC (006935977)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    HK KOLMAR CANADA, INC243501959manufacture(36800-443) , pack(36800-443)
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