Label: WALGREENS MAXIMUM STRENGTH- benzocaine 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 October 20, 2021

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

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

    Stop use and ask a 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 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.

  • STORAGE AND HANDLING

    Other information

    • do not use if package has been opened
    • tore 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 Artificial Flavor, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin, Water

  • SPL UNCLASSIFIED SECTION

    Questions or comments? 1-800-925-4733

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD. DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    www.walgreens.com

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL

    Card R5

  • INGREDIENTS AND APPEARANCE
    WALGREENS  MAXIMUM STRENGTH
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5820
    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
    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)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    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:0363-5820-481 in 1 BLISTER PACK06/14/2016
    114.7 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/01/2015
    Labeler - Walgreens (008965063)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    CSR Cosmetic Solutions Inc.243501959manufacture(0363-5820)