Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 0283-0871-31
  • Packager: Beutlich Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 28, 2024

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

    Allergy alert: Do not use if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

  • Stop use and ask a doctor

    • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting
    • if sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens
  • When using this product

    • avoid contact with eyes
  • 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:  consult a dentist or doctor

  • Other information

    • do not use if imprinted seal under cap is broken or missing
    • store at 20°-25° C (68°- 77° F)
  • Inactive ingredients

    flavor, polyethylene glycol, sodium saccharin

  • Questions or comments?

    1-800-238-8542

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

  • Principal Display Panel

    NDC 0283-0871-31

    HURRICAINE®

    Topical Anesthetic GEL

    20% Benzocaine Oral Anesthetic

    ORIGINAL WILD CHERRY

    Manufactured for:

    Beutlich® Pharmaceuticals, LLC

    Bunnell, FL 32110

    1 oz.

    Principal Display

  • INGREDIENTS AND APPEARANCE
    HURRICAINE  TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0871
    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
    Colorbrown (amber) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0283-0871-311 in 1 BOX08/15/1971
    128.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02208/15/1971
    Labeler - Beutlich Pharmaceuticals, LLC (005209325)
    Registrant - Beutlich Pharmaceuticals, LLC (005209325)
    Establishment
    NameAddressID/FEIBusiness Operations
    Speciality Pharma Manufacturing, LLC013957125manufacture(0283-0871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies Inc.148312838manufacture(0283-0871)