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HurriCaine Topical Anesthetic by Beutlich Pharmaceuticals, LLC

Dosage form: spray
Ingredients: BENZOCAINE 200mg in 1g
Labeler: Beutlich Pharmaceuticals, LLC
NDC Code: 0283-0679

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 Facts

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

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.

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.

Stop use and ask a doctor if
  • sore throat is severe, persists for more than 2 days, is accompanied or followed by 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 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
  • 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: consult a dentist or doctor

Inactive ingredients

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

Questions or comments?

1-800-238-8542 or 1-847-473-1100

M-F: 8:00 a.m. - 4:30 p.m. CST

Principal Display Panel

HURRICAINE  TOPICAL ANESTHETIC
benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0679
Route of AdministrationORAL, DENTAL, PERIODONTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400349 mg  in 1 g
SACCHARIN SODIUM12 mg  in 1 g
CHERRY439 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0283-0679-0259.7 g in 1 CAN
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/FEIOperations
Precise Packaging194325999manufacture(0283-0679)

Revised: 09/2014
 
Beutlich Pharmaceuticals, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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