Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 0283-0871-01, 0283-0871-12, 0283-0871-75
  • 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 October 31, 2019

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 procedures
    • 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.

    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 the tube has been punctured or 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 accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Directions:

    Do not exceed recommended 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: do not use
  • Other information

    • store at 20°-25° C (68°-77° F)

  • Inactive ingredients

    • 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

    tube packaging image

    WHAT YOUR DENTIST USES

    NDC 0283-0871-75

    HURRICAINE®

    Topical Anesthetic GEL

    20% Benzocaine Oral Anesthetic

    ORIGINAL WILD CHERRY

    Manufactured for:

    Beutlich® Pharmaceuticals, LLC

    Bunnell, FL

    Made in the USA

    1 Tube - NET WT. 0.18 oz. (5.25 g)

  • INGREDIENTS AND APPEARANCE
    HURRICAINE   TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0871
    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)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorbrown (amber) Score    
    ShapeSize
    FlavorCHERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0283-0871-1212 in 1 CELLO PACK08/15/1971
    1NDC:0283-0871-751 in 1 BOX
    1NDC:0283-0871-015.25 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/15/1971
    Labeler - Beutlich Pharmaceuticals, LLC (005209325)
    Registrant - Beutlich Pharmaceuticals, LLC (005209325)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies, Inc.148312838manufacture(0283-0871)