HURRICAINE- topical anesthetic spray 
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 One
Drug Facts

Active Ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

Uses for the temporary relief of occasional minor irritation and pain associated with sore mouth and throat

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 accidently swallowed, get medical help or contact a Poison Control Center Immediately

Directions

adults and children 2 years of age and older: 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 goycol, sodium saccharin

Questions or comments?

1-800-238-4582

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

Principal Display Panel

HurriCaine One 2ct carton

HurriCaine One 2ct carton

Principal Display Panel

HO25B 596 0518 25ct carton.jpg

HurriCaine One 25ct carton

HURRICAINE 
topical anesthetic spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0283-0610
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) 349 mg  in 1 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 12 mg  in 1 g
CHERRY (UNII: BUC5I9595W) 439 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-0610-112 in 1 BOX04/01/2016
1NDC:0283-0610-430.492 g in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:0283-0610-2625 in 1 BOX04/01/2016
2NDC:0283-0610-430.492 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/2010
Labeler - Beutlich Pharmaceuticals LLC (005209325)
Registrant - Beutlich Pharmaceuticals LLC (005209325)
Establishment
NameAddressID/FEIBusiness Operations
SPECIALITY PHARMA MANUFACTURING, LLC013957125manufacture(0283-0610)

Revised: 8/2019
Document Id: 44447117-3854-4039-809d-4292c51a284a
Set id: 255fba91-6357-4414-ad23-a18694ef886b
Version: 23
Effective Time: 20190827
 
Beutlich Pharmaceuticals LLC