Label: HURRICAINE TOPICAL ANESTHETIC- benzocaine gel

  • NDC Code(s): 0283-0220-34, 0283-0220-43
  • 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 January 22, 2021

If you are a healthcare professional or from the pharmaceutical industry 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 tray seal is broken or missing
    • if cap is missing 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.

  • 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

    4ct Syringe box - Watermelon

    Gel Syringe Unit: 0283-1820-43  1.5g in 1 syringe

    Gel Syringe Pack of 4:  0283-1820-34  4 x 1.5g in 1 box.

    Syringe label - Watermelon

  • INGREDIENTS AND APPEARANCE
    HURRICAINE   TOPICAL ANESTHETIC
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0220
    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
    Color    Score    
    ShapeSize
    FlavorWATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0283-0220-344 in 1 BOX01/31/2021
    1NDC:0283-0220-431.5 g in 1 SYRINGE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/31/2021
    Labeler - Beutlich Pharmaceuticals, LLC (005209325)
    Registrant - Beutlich Pharmaceuticals, LLC (005209325)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dental Technologies, Inc.148312838manufacture(0283-0220)