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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HurriCaine Gel W/C Tubes

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

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.

Other information

Inactive ingredients

Questions or comments?

1-800-238-8542

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

Principal Display Panel

tube packaging image

WHAT YOUR DENTIST USES

NDC 0283-0871-75

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

ORIGINAL WILD CHERRY

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL

Made in the USA

1 Tube - NET WT. 0.18 oz. (5.25 g)

HURRICAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0871
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)  
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Colorbrown (amber) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-0871-1212 in 1 CELLO PACK08/15/1971
1NDC:0283-0871-751 in 1 BOX
1NDC:0283-0871-015.25 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/15/1971
Labeler - Beutlich Pharmaceuticals, LLC (005209325)
Registrant - Beutlich Pharmaceuticals, LLC (005209325)
Establishment
NameAddressID/FEIBusiness Operations
Dental Technologies, Inc.148312838manufacture(0283-0871)

Revised: 1/2023
Document Id: f1eb64e8-05c2-931b-e053-2995a90a2fe8
Set id: 113cdb83-0fdd-40f2-8ee6-b771dca99713
Version: 23
Effective Time: 20230110
 
Beutlich Pharmaceuticals, LLC