WALGREENS MAXIMUM STRENGTH (BENZOCAINE) LIQUID [WALGREENS]

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WALGREENS MAXIMUM STRENGTH (BENZOCAINE) LIQUID [WALGREENS]
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NDC 0363-5820-48
Set ID 8f24309d-d393-455a-a9a5-a55344adf36b
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class
Product Number
Application Number PART333B
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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 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)
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