Label: HURRICAINE- topical anesthetic spray

  • NDC Code(s): 0283-0610-11, 0283-0610-26, 0283-0610-43
  • Packager: Beutlich Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL

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 August 27, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Benzocaine 20%

  • Purpose

    Oral Anesthetic

  • Uses

    Uses for the temporary relief of occasional minor irritation and pain associated with sore mouth and throat

  • 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.

    ​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

    • if foil pouch has been previously opened
    • 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 accidently 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: 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

  • Other information

    • store at 15-30 °C (59-86 °F)
  • Inactive ingredients

    flavor, polyethylene goycol, sodium saccharin

  • Questions or comments?

    1-800-238-4582

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

  • Principal Display Panel

    HurriCaine One 2ct carton

    HurriCaine One 2ct carton

  • Principal Display Panel

    HO25B 596 0518 25ct carton.jpg

    HurriCaine One 25ct carton

  • INGREDIENTS AND APPEARANCE
    HURRICAINE 
    topical anesthetic spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0610
    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) 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:0283-0610-112 in 1 BOX04/01/2016
    1NDC:0283-0610-430.492 g in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:0283-0610-2625 in 1 BOX04/01/2016
    2NDC:0283-0610-430.492 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/15/2010
    Labeler - Beutlich Pharmaceuticals LLC (005209325)
    Registrant - Beutlich Pharmaceuticals LLC (005209325)
    Establishment
    NameAddressID/FEIBusiness Operations
    SPECIALITY PHARMA MANUFACTURING, LLC013957125manufacture(0283-0610)