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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Mint Gel

Active ingedient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

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

Warnings

Allergy alert: ​Do not use if you have a history of allergy to local anesthetics such as procaine, butaine, benzocaine or other "caine" anesthetics.

Stop use and ask doctor if

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.

Adverse Reactions:

Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.

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: consult a dentist or doctor

Other information

Inactive ingredient

flavor, polyethylene glycol, sodium saccharin

Questions or comments?

1-800-238-8542

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

Principal Display Panel

1oz gel carton image

NDC 0283-0998-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

FRESH MINT

Manufactured for:

Beutlich®

Pharmaceuticals, LLC

Bunnell, FL

www.beutlich.com

HURRICAINE  TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0998
Route of AdministrationDENTAL, 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
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-0998-3128.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1998
2NDC:0283-0998-431 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 finalpart35609/15/1998
Labeler - Beutlich Pharmaceuticals LLC (005209325)
Registrant - Beutlich Pharmaceuticals LLC (005209325)
Establishment
NameAddressID/FEIBusiness Operations
Dental Technologies148312838manufacture(0283-0998)
Establishment
NameAddressID/FEIBusiness Operations
Speciality Pharma Manufacturing013957125manufacture(0283-0998)

Revised: 1/2020
Document Id: 03b69d07-2a1a-4572-9291-8cd5480ecc68
Set id: 723da3ae-3f1f-4962-920b-f2a30c8c3253
Version: 35
Effective Time: 20200108
 
Beutlich Pharmaceuticals LLC