• NDC Code(s): 0283-0293-31, 0283-0293-43
  • Packager: Beutlich Pharmaceuticals, LLC
  • 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 December 24, 2019

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

  • Active ingredient

    Benzocaine 20%

  • Purpose

    Oral Anesthetic

  • Uses

    for the temporary relief of occasional minor irritation and pain associated with:

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

    Methemoglobinemia warning:
    Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in 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: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

  • Do not use

    Do not use
    • if imprinted seal under cap is broken or missing
    • for teething
    • in children under 2 years of age

  • When using this product

    When using this product: avoid contact with eyes

  • Keep out of reach of children

    Keep out of reach of children. If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • do not exceed recommended dosage

    adults and children 2 years of age and older: apply to the affected area. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor.

    children under 12 years of age: should be supervised in the use of the product

    children under 2 years of age: do not use

  • Other information

    Other information
    store at 20°-25° C (68°- 77° F)

  • Inactive ingredient

    flavor, polyethylene glycol, sodium saccharin

  • Questions or comments?


    M-F: 8:00 a.m. to 4:30 p.m. ET

  • Principal Display Panel

    1oz Watermelon Gel Carton image

    NDC 0283-0293-31


    Topical Anesthetic GEL

    20% Benzocaine Oral Anesthetic


    Manufactured for:

    Beutlich Pharmaceuticals LLC

    Bunnell, FL 32110

    Made in the USA

    1 oz.

    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0293
    Route of AdministrationORAL, DENTAL, PERIODONTAL
    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 400 (UNII: B697894SGQ)  
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorwhite (colorless) Score    
    FlavorWATERMELONImprint Code
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0283-0293-3128.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/15/1993
    2NDC:0283-0293-431 g in 1 PACKET; Type 0: Not a Combination Product01/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/15/1993
    Labeler - Beutlich Pharmaceuticals, LLC (005209325)
    NameAddressID/FEIBusiness Operations
    Dental Technologies Inc.148312838manufacture(0283-0293)
    NameAddressID/FEIBusiness Operations
    Speciality Pharma Manufacturing013957125manufacture(0283-0293)