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 February 13, 2012

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  • Drugs Facts

    Active Ingredients Purpose
    Benzocaine 20% Oral Anesthetic
  • Uses

    For control of pain; Topical anesthetic for oral or mucosal areas. To
    suppress the gag reflex.
  • Directions

    May be used with extension tube for finer direct application. For anesthetic
    use in mouth or throat: pump spray 2-3 times or as needed. Repeat if needed
    for larger areas. Anesthetic effect is reached in 15-30 seconds.
  • DOSAGE & ADMINISTRATION

    Children under 6yrs of age use as directed by dentist/doctor.
  • 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:
    Π Avoid use near eyes Π Do not use more than recommended dosage
    Π 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

    Benzyl alcohol, flavor, polyethylene glycol, SDA38B,
    Sodium Saccharine
  • Storage

    store at controlled room temperature 20-25°C (68-77°F)
  • Keep out of reach of children

    KEEP OUT OF REACH OF CHILDREN
  • PRINCIPAL DISPLAY PANEL

    Label of BottleEnter section text here

  • INGREDIENTS AND APPEARANCE
    BENZ O STHETIC 
    benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-925
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE (UNII: 3X5A8DP6HC)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY (CHERRY) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-925-0259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/13/2012
    Labeler - Geritrex Corp. (112796248)
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