Label: BENCOCAINE TOPICAL ANESTHETIC- 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 September 21, 2023

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

  • Active Ingredients

    Benzocaine 200 mg (in each g)

  • Purpose

    Oral Anesthetic

  • INDICATIONS & USAGE

    For oral mucosal use only, as directed by dentist. For the temporary relif of pain due to minor dental procedures.

  • Warnings

    Warnings
    Methemoglolllnemla
    warning: Use of this product
    may cause methemoglobinemia,
    a seriouscondit~n that must be
    treated promptly because tt
    reduces the amount of oxygen
    carried in the blood. This can
    occur even if you have used this
    product before. Stop use and
    seek immediate medical
    attention if you or a child in your
    care develops:
    • pale, gray or blue colored skin
    (cyanosis)
    •headache

    • rapid heart rate

    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

  • Allergy Alert

    Allergy Alert Do not use on
    patients with a history of
    allergies to local anesthetics
    suchasprocaine,butacaine,
    benzocaine or other "caine"
    anesthetics.

  • Do not use

    •for more than 7 days unless directed by a physician. If sore mouth symptoms do not improve in 7 days; irritation, pain, or redness persists or worsens; or worsens; or if swelling, rash or fever develops,see your physician promptly.
    • for teething
    •in children under 2 years of age

  • When using this product

    Avoid contact with eyes. If contact occurs, flush with water.

  • Do not exceed recommended dosage

    If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • If pregnant or breast feeding,

    ask a physician before use.

  • Keep out of reach of children

  • Directions

    • Apply only amount needed to
    the oral mucosa to prevent or
    relieve pain.
    • children under 2 years of age:
    do not use

  • Other Information

    Store at 59 -86°F(15-30°C).
    Protect from freezing.

  • Inactive Ingredients

    flavoring, PEG 3350, PEG 400, sodium saccharin.

  • Questions or Comments?

    800.GO.BENCO or benco.com

  • PRINCIPAL DISPLAY PANEL

    Bencocaine Topical Wrap_dye-free_99091791

  • INGREDIENTS AND APPEARANCE
    BENCOCAINE TOPICAL ANESTHETIC 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66975-341
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Product Characteristics
    Colorwhite (DYE-FREE) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66975-341-3030 g in 1 JAR; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/01/2020
    Labeler - Benco Dental (015108087)