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 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 imprinted seal under cap is broken or missing      
• 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

NDC 0283-1016-31

1oz Gel Carton Image
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, 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
ColoryellowScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-1016-311 in 1 BOX10/15/2016
1NDC:0283-1016-0028.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:0283-1016-431 g in 1 PACKET; Type 0: Not a Combination Product01/28/2020
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
Speciality Pharma Manufacturing013957125manufacture(0283-1016)

Revised: 1/2020
Document Id: 7cfe03e5-2feb-4061-a71f-fd71239bc997
Set id: 42521b29-67e4-4a16-848d-7e6ba4a7ece2
Version: 35
Effective Time: 20200108
 
Beutlich Pharmaceuticals, LLC