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HurriCaine Topical Anesthetic by Beutlich Pharmaceuticals, LLC

Medically reviewed on November 29, 2016

Dosage form: gel
Ingredients: BENZOCAINE 200mg in 1g
Labeler: Beutlich Pharmaceuticals, LLC
NDC Code: 0283-1016

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 procedures
  • 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.

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
  • if sore mouth symptoms do not improve in 7 days, or irritation, pain, or redness persists or worsens

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
  • 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: consult a dentist or doctor

Other information
  • do not use if imprinted seal under cap is broken or missing
  • 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

Principle Display Panel

NDC 0283-1016-31
HURRICAINE®
Topical Anesthetic GEL
20% Benzocaine Oral Anesthetic
STRAWBERRY
Manufactured for:
Beutlich® Pharmaceuticals, LLC
Bunnell, FL 32110
1 oz.

HURRICAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-1016
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 400 
SACCHARIN SODIUM 
POLYETHYLENE GLYCOL 3500 
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0283-1016-311 BOTTLE, PLASTIC in 1 BOX
1NDC:0283-1016-0028.4 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/15/2016
Labeler - Beutlich Pharmaceuticals, LLC (005209325)
Registrant - Beutlich Pharmaceuticals, LLC (005209325)
Establishment
NameAddressID/FEIOperations
Dental Technologies148312838manufacture(0283-1016)
Establishment
NameAddressID/FEIOperations
Water-Jel Technologies155522589manufacture(0283-1016)
Establishment
NameAddressID/FEIOperations
Pharmasol Corporation065144289manufacture(0283-1016)

 
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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