Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 0283-0871-31
  • Packager: Beutlich Pharmaceuticals, LLC
  • 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 27, 2023

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 AdministrationDENTAL, ORAL, 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 not finalpart35608/15/1971
    Labeler - Beutlich Pharmaceuticals, LLC (005209325)
    Registrant - Beutlich Pharmaceuticals, LLC (005209325)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies Inc.148312838manufacture(0283-0871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Speciality Pharma Manufacturing, LLC013957125manufacture(0283-0871)