Label: WALGREENS SEVERE ORAL PAIN RELIEVER- 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/analgesic

  • INDICATIONS & USAGE

    Use

    for the temporary relief of pain due to canker sores, minor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums

  • WARNINGS

    Warnings

    For oral use only
    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

    • do not use for more than 7 days unless told to do so by a dentist or doctor If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or, if swelling, rash or fever develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • to assure formation of long lasting film coating, dry affected area and apply medication undiluted with applicator.
    • allow a few seconds for coating to form.
    • use up to 4 times daily, or as directed by a dentist or doctor.
    • children 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 purchase if package has been opened
    • store at 20 - 25 C (68-77F)
    • close cap tightly after use to avoid evaporation
    • avoid contact with eyes
    • avoid contact with clothing and household furniture surfaces to avoid possible staining
    • this is a personal care item, and should be used by one individual only
  • INACTIVE INGREDIENT

    Inactive ingredients

    Benzyl Alcohol, Cetylpyridinium Chloride, Compound Benzoin Tincture, Dimethyl Isosorbide, Ethylcellulose, Flavor, Octylacrylamideacrylates/butylaminoethyl/methacrylate Copolymer, Oleth-10, PEG-6, Propylene Glycol, Ricinus Communis (Castor)
    Seed Oil, SD Alcohol 38B, Sucralose, Tannic Acid.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED

    walgreens.com

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL

    Card R4

  • INGREDIENTS AND APPEARANCE
    WALGREENS  SEVERE ORAL PAIN RELIEVER
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5335
    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
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)  
    TANNIC ACID (UNII: 28F9E0DJY6)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    OLETH-10 (UNII: JD797EF70J)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    RICINUS COMMUNIS SEED (UNII: 7EK4SFN1TX)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    BENZOIN RESIN (UNII: GK21SBA74R)  
    Product Characteristics
    Coloryellow (orange to reddish orange) Score    
    ShapeSize
    FlavorMINT (Mint Flavor #25797) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5335-511 in 1 BLISTER PACK01/10/2012
    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 not finalpart35601/10/2012
    Labeler - Walgreens (008965063)
    Registrant - Lornamead Inc. (078584069)
    Establishment
    NameAddressID/FEIBusiness Operations
    CSR Cosmetic Solutions243501959manufacture(0363-5335)