Label: ORAL ANALGESIC MAXIMUM STRENGTH- benzocaine gel

  • 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 August 17, 2010

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

  • Oral Analgesic (Maximum Strength)

    Active Ingredient

    Benzocaine 20%

  • PURPOSE

    Purpose

    Oral pain reliever


    Uses

    temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters,  minor irritation of the mouth and gums caused by dentures or orthodontic appliances

  • WARNINGS

    Warnings

    for temporary use only until a dentist can be consulted



    Allergy alert:

    do not use this product if you have a history of allergy to local anesthetics such a procaine, butacaine, benzocaine or other "caine" anesthetics.

  • INDICATIONS & USAGE

    When using this product

    • do not use more than directed
    • do not use for more than 7 days unless directed by a doctor/dentist
    • do not use more than 4 times in a 24 hour period unless directed by a doctor/dentist
  • STOP USE

    Stop use and ask a doctor 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

    Keep out of reach of children.

    In cases of overdose, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • remove cap and cut tip of tube on score mark
    • adults and children 2 years of age and older: apply a small amount of Oral Analgesic Gel to the cavity and around gum surrounding the teeth. use up to 4 times daily or as directed by a doctor or dentist.
    • children under 12 year of age: should be supervised in the use of this product
    • children under 2 years of age: ask a doctor/dentist
  • STORAGE AND HANDLING

    Other information

    • store at 15o to 25o (50o to 77oF)
    • This preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist can be consulted. Do not use continuously
    • Lot No. and Exp. Date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive Ingredients

    d-sorbitol solution, glycerin, peppermint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium

  • QUESTIONS

    Questions?

    Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

  • PRINCIPAL DISPLAY PANEL

    Image of Oral Analgesic Gel Carton Label

    Image of Oral Analgesic Gel Tube Label




  • INGREDIENTS AND APPEARANCE
    ORAL ANALGESIC  MAXIMUM STRENGTH
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Peppermint (UNII: V95R5KMY2B)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Polyethylene Glycol 4000 (UNII: 4R4HFI6D95)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51852-101-011 in 1 CARTON
    111.9 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/01/2010
    Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)