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 - Cherry 1oz

Active ingredient

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, butacaine, benzocaine or other "caine" anesthetics.

Stop use and ask a doctor

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


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 ingredients

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

NDC 0283-0871-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

ORIGINAL WILD CHERRY

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

1 oz.

Principal Display

HURRICAINE   TOPICAL ANESTHETIC
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0871
Route of AdministrationDENTAL, ORAL, 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:0283-0871-311 in 1 BOX08/15/1971
128.4 g in 1 BOTTLE, PLASTIC; 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)
Establishment
NameAddressID/FEIBusiness Operations
Speciality Pharma Manufacturing, LLC013957125manufacture(0283-0871)

Revised: 9/2023
Document Id: 065d760b-7098-3e26-e063-6394a90a48cd
Set id: 1f3d68f6-afd6-42e7-b3e5-210228c8e7de
Version: 26
Effective Time: 20230927
 
Beutlich Pharmaceuticals, LLC