Label: BENZ O STHETIC- benzocaine spray

  • 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 September 28, 2017

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

  • Drugs Facts

    Active Ingredients                       Purpose
    Benzocaine 20%........................Oral Anesthetic

  • Uses

    Topical anesthetic for the temporary relief of occasional minor irritation and pain, associated with:
    canker sores

    • sore mouth and throat
    • minor dental procedures
    • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
    • minor injury of the mouth and gums

  • Directions

    May be used with extension tube for finer direct application. For adults and children 2 years and older anesthetic use in mouth or throat:
    Pump spray 2-3 times up to 4 times. Repeat if needed for larger areas. Anesthetic effect is reached in 15-30 seconds. Children under 12 years of age should be supervised and use as directed by dentist/doctor.

  • INDICATIONS & USAGE

  • Warnings


    Do not use this product if patient has a history of allergy to local anesthetics
    such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Do not
    spray into or near eyes. Do not inhale.

    Patient: When using extension tube, do not spray in the back of the throat
    unless your dentist or doctor directed you to do so.

    When using this product:

    • Avoid use near eyes
    • Do not use more than recommended dosage
    • Do not go beyond 7 days usage, unless directed by your doctor/dentist

    Patient: Discontinue use and consult a physician if: sore mouth symptoms do
    not improve in 5 days; irritation, pain, or redness persists or worsens;
    swelling, rash, or fever develops.

  • Other Ingredients

    Alcohol, benzyl alcohol, flavor, peppermint oil, polyethylene glycol, sodium saccharin

  • Other Information:

    store at controlled room temperature 20-25°C (68-77°F)

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • WARNINGS AND PRECAUTIONS

    Caution:​ ​If accidental or excessive ingestion occurs (exceeds recommended dosage) contact a physician for immediate advice or call a Poison Control Center. 

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BENZ O STHETIC 
    benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-929
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE11.8 g  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-929-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2017
    Labeler - Geritrex LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex LLC112796248manufacture(54162-929)