HURRICAINE  TOPICAL ANESTHETIC- benzocaine gel 
Beutlich Pharmaceuticals, LLC

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.

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SB Unit Dose Gel

Active Ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

for the temporary relief of occasional minor irritation and pain, associated with

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 product film is punctured or damaged   
• for teething
• in children under 2 years of age

When using this product

When using this product avoid contact with eyes

Keep out of reach of children.

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

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

Other information

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

unit dose gel Strawberry

HurriCaine Unit Dose Gel Strawberry 0.5g with Swab: 0283-1016-45

60ct HurriCaine Unit Dose Gel Strawberry 0.5g with Swab: 0283-1016-59

60ct box unit dose gel Strawberry

HURRICAINE   TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-1016
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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYETHYLENE GLYCOL 3500 (UNII: FVS1AZD90Y)  
Product Characteristics
Coloryellow (colorless to pale yellow) Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-1016-5960 in 1 BOX01/31/2021
1NDC:0283-1016-450.5 g in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package
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/FEIBusiness Operations
Dental Technologies148312838manufacture(0283-1016)
Establishment
NameAddressID/FEIBusiness Operations
Centrix Inc.053707303label(0283-1016)
Establishment
NameAddressID/FEIBusiness Operations
Beutlich Pharmaceuticals, LLC005209325label(0283-1016) , pack(0283-1016)

Revised: 3/2023
Document Id: f5eec054-6eb0-1ecc-e053-2995a90ab6b8
Set id: 0605d5d6-82bd-415e-b5cb-e273f934a4a7
Version: 5
Effective Time: 20230302
 
Beutlich Pharmaceuticals, LLC