HURRICAINE TOPICAL ANESTHETIC LIQUID- benzocaine liquid 
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.

----------

W/C Liquid

Active ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

for 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

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

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 0283-0569-31

1oz carton image

HURRICAINE®

Topical Anesthetic LIQUID

20% Benzocaine Oral Anesthetic

ORIGINAL WILD CHERRY

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

Made in the USA

1 fl. oz. 

NDC: 0283-0569-72

72ct carton image

NDC: 0283-0569-02 

2ct Snap-n-Go Swab

HURRICAINE  TOPICAL ANESTHETIC LIQUID
benzocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0569
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)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-0569-3129.6 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/15/1969
2NDC:0283-0569-171 g in 1 PACKET; Type 0: Not a Combination Product01/28/2020
3NDC:0283-0569-7272 g in 1 APPLICATOR; Type 0: Not a Combination Product05/15/1969
4NDC:0283-0569-022 g in 1 APPLICATOR; Type 0: Not a Combination Product05/15/1969
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/15/1969
Labeler - Beutlich Pharmaceuticals, LLC (005209325)
Registrant - Beutlich Pharmaceuticals, LLC (005209325)
Establishment
NameAddressID/FEIBusiness Operations
Dental Technologies Inc.148312838manufacture(0283-0569)
Establishment
NameAddressID/FEIBusiness Operations
Speciality Pharma Manufacturing013957125manufacture(0283-0569)
Establishment
NameAddressID/FEIBusiness Operations
SWABPLUS116984439manufacture(0283-0569)

Revised: 1/2020
Document Id: be9c775b-51db-4a46-a1be-91aac19d13c2
Set id: fee9969d-ad1a-4f44-9741-a0a44c9e1128
Version: 35
Effective Time: 20200108
 
Beutlich Pharmaceuticals, LLC