Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 0283-0998-31, 0283-0998-43
  • 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 January 8, 2020

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
  • 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

    1oz gel carton image

    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
    2NDC:0283-0998-431 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 finalpart35609/15/1998
    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)