Label: GOOD NEIGHBOR PAIN RELIEF- 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 June 27, 2013

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  • Active ingredient

    Benzocaine, 20%

  • Purpose

    Oral anesthetic

  • Uses

    Provides temporary relief of pain associated with the following mouth and gum irritations:

    • toothache
    • sore gums
    • canker sores
    • braces
    • minor dental procedures
    • dentures
  • 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 doctor or dentist
  • 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 more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away
  • Directions

    • Adults and children 2 years of age and older:
    • wipe liquid on with cotton, or cotton swab, or finger tip.
    • apply to the affected area up to 4 times daily of as directed by a doctor or dentist.
    • Children under 12 years of age: adult supervision should be given in the use of this product.
    • Children under 2 years of age: consult a doctor or dentist.
  • Inactive ingredients

    Benzyl alcohol, FD&C Blue #1, FD&C Red #40, D&C yellow #10, Flavor, Methylparaben, Polyethylene Glycol, Propylene Glycol, Saccharin

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PAIN RELIEF 
    benzocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-030
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN (UNII: FST467XS7D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-030-051 in 1 BLISTER PACK
    1NDC:46122-030-0615 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/01/2008
    Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) (007914906)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    AmerisourceBergen Drug Corporation007914906label(46122-030)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432pack(46122-030)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unipack009248480manufacture(46122-030)
    Establishment
    NameAddressID/FEIBusiness Operations
    Samson Pharmaceuticals088169581manufacture(46122-030)