Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine spray

  • NDC Code(s): 0283-0679-02
  • 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 July 15, 2021

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 proedures
    • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
  • Warnings

    Methemoglobinemia warning:Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops:
    • pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

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

    Flammable. Do not use near fire or flame. Avoid smoking during use.

    Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly. If sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens, see your dentist or doctor promptly.

  • Do not use

    Do not use
    • for teething
    • in children under 2 years of age

  • When using this product

    When using this product

    • avoid spraying in eyes
    • do not store at temperature above 49 °C (120 °F)
    • do not puncture or incinerate. Contents under pressure.
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
  • 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

    Directions:

    • do not exceed recommended dosage
    • firmly insert extension tube into spray can valve and ensure it fits securely into the actuator opening
    • position the extension tube 1-2 inches from the affected area
    • spray 1/2 second (press and immediately release actuator)
    • repeat once if necessary
    • anesthesia is accomplished in approximately 20 seconds

    adults and children 2 years of age and older: 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: do not use.

  • Inactive ingredients

    flavor, hydrocarbon propellant (isobutane and propane), polyethylene glycol, sodium saccharin

  • Questions or comments?

    1-800-238-8542

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

  • Product Label

    primary label

  • INGREDIENTS AND APPEARANCE
    HURRICAINE  TOPICAL ANESTHETIC
    benzocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0679
    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) 349 mg  in 1 g
    SACCHARIN SODIUM (UNII: SB8ZUX40TY) 12 mg  in 1 g
    CHERRY (UNII: BUC5I9595W) 439 mg  in 1 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0283-0679-0259.7 g in 1 CAN; Type 0: Not a Combination Product06/15/1979
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/15/1979
    Labeler - Beutlich Pharmaceuticals, LLC (005209325)
    Registrant - Beutlich Pharmaceuticals, LLC (005209325)
    Establishment
    NameAddressID/FEIBusiness Operations
    Precise Packaging, LLC194325999manufacture(0283-0679)