Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 0283-0998-31
  • Packager: Beutlich Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2025

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  • Active ingedient

    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, butaine, benzocaine or other "caine" anesthetics.

  • Stop use and ask doctor if

    • sore throat is severe, persists for more than 2 days, is accompanied or followed by a fever, headache, rash, swelling, nausea or vomiting
    • sore mouth symptoms do not improve in 7 days, or if 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.

  • Adverse Reactions:

    Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.

  • Directions

    • do not exceed recommend 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 ingredient

    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

    image of 1oz carton

    NDC 0283-0998-31

    HURRICAINE®

    Topical Anesthetic GEL

    20% Benzocaine Oral Anesthetic

    FRESH MINT

    Manufactured for:

    Beutlich®

    Pharmaceuticals, LLC

    Bunnell, FL

    www.beutlich.com

  • INGREDIENTS AND APPEARANCE
    HURRICAINE  TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0998
    Route of AdministrationDENTAL, 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
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0283-0998-3128.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02209/15/1998
    Labeler - Beutlich Pharmaceuticals LLC (005209325)
    Registrant - Beutlich Pharmaceuticals LLC (005209325)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies148312838manufacture(0283-0998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Speciality Pharma Manufacturing013957125manufacture(0283-0998)