WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]

WALGREENS MAXIMUM STRENGTH (BENZOCAINE) PASTE, DENTIFRICE [WALGREENS]
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NDC 0363-5337-19
Set ID 2ef0eb2c-b614-44e2-b9b3-97b02c654977
Category HUMAN OTC DRUG LABEL
Packager Walgreens
Generic Name
Product Class
Product Number
Application Number PART333B
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzocaine 20%

  • PURPOSE

    Purpose

    Oral pain reliever

  • INDICATIONS & USAGE

    Use for the temporary relief of pain due to:

    • canker sores
    • cold sores
    • fever blisters
    • minor irritation of the mouth and gums
    • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
  • 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 use more than directed
    • do not use for more than 7 days unless told to do so 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

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

  • DOSAGE & ADMINISTRATION

    Directions

    • cut open tip of tube on score mark
    • adults and children 2 years of age and older: apply to the affected area 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
    • for denture irritation apply a thin layer to the affected area; do not reinsert dental work until irritation/pain is relieved; rinse mouth well after reinserting
  • OTHER SAFETY INFORMATION

    Other information Do not use if tip is cut prior to opening. This preparation is intended for use in cases of toothache, only as a

    temporary expedient until a dentist can be consulted. Do not use continuously.

  • INACTIVE INGREDIENT

    Inactive ingredients Cellulose Gum, Gelatin, Menthol, Methyl Salicylate, Pectin, Petrolatum, Polyethylene Glycol, Sodium Saccharin.

  • SPL UNCLASSIFIED SECTION

    Questions or comments? 1-877-777-2743

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    walgreens.com

    MADE IN U.S.A.

  • PRINCIPAL DISPLAY PANEL

    Carton R2

  • INGREDIENTS AND APPEARANCE
    WALGREENS  MAXIMUM STRENGTH
    benzocaine paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5337
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GELATIN (UNII: 2G86QN327L)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SACCHARIN (UNII: FST467XS7D)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    PECTIN (UNII: 89NA02M4RX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorWINTERGREEN (L Menthol) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5337-191 in 1 CARTON08/01/2013
    112 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/01/2013
    Labeler - Walgreens (008965063)
    Registrant - Lornamead (126440440)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(0363-5337)

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