Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 0283-0998-45, 0283-0998-59
  • 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 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


    DO NOT USE:

    • if the product film is punctured or damaged
    • for teething

    • in children under 2 years of age

  • 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

    Unit Dose Gel - Mint - 0.5g

    HurriCaine Unit Dose Gel Mint 0.5g with Swab: 0283-0998-45

    60ct HurriCaine Unit Dose Gel Mint 0.5g with Swab: 0283-0998-59

    60ct Box Mint

  • 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:0283-0998-5960 in 1 BOX01/31/2021
    1NDC:0283-0998-450.5 g in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package
    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
    Beutlich Pharmaceuticals, LLC005209325label(0283-0998) , pack(0283-0998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Centrix Inc.053707303label(0283-0998)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies148312838manufacture(0283-0998)