HURRICAINE TOPICAL ANESTHETIC- benzocaine gel 
Beutlich Pharmaceuticals, LLC

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HurriCaine Gel Syringe 1.2g - Pina Colada

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

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:
• 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

Storage and Handling

Inactive ingredients

flavor, polyethylene glycol, sodium saccharin

Questions or comments?

1-800-238-8542

M-F: 8:00 a.m. to 4:30 p.m. ET

Principal Display Panel

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

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

HURRICAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-1820
Route of AdministrationDENTAL, PERIODONTAL, ORAL
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
Coloryellow (yellow to pale orange) Score    
ShapeSize
FlavorCOCONUT (Pina Colada Flavor) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-1820-344 in 1 TRAY07/01/202303/31/2026
1NDC:0283-1820-431.5 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 DrugM02202/28/2021
Labeler - Beutlich Pharmaceuticals, LLC (005209325)
Registrant - Beutlich Pharmaceuticals, LLC (005209325)

Revised: 7/2023
Document Id: fe921a82-8035-f0fd-e053-6394a90af4af
Set id: fe92637a-c88a-f9dd-e053-6294a90a7fa3
Version: 4
Effective Time: 20230701
 
Beutlich Pharmaceuticals, LLC