Your browser does not support JavaScript! HURRICAINE TOPICAL ANESTHETIC SPRAY (BENZOCAINE) SPRAY [BEUTLICH LP, PHARMACEUTICALS]
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HURRICAINE TOPICAL ANESTHETIC SPRAY (benzocaine) spray
[Beutlich LP, Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Benzocaine 20%

Purpose

Oral Anesthetic

Uses

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

  • canker sores
  • sore mouth and throat
  • minor dental procedures
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
  • minor injury of the mouth and gums

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.

Flammable. Do not use near fire or flame. Avoid smoking during use.

Stop use and ask a doctor

  • if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, swelling, nausea or vomiting
  • if sore mouth symptoms do not improve in 7 days, or if irritation, pain, or redness persists or worsens

When using this product

  • avoid contact with eyes
  • do not store at temperature above 49°C (120°F)
  • do not puncture or incinerate. Contents under pressure.
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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

  • do not exceed recommended dosage
  • firmly insert the extension tube into spray can valve and ensure it fits securely into the actuator opening
  • position the extension tube 1-2 inches from affected area
  • spray 1/2 second (press and immediately release actuator)
  • repeat once if necessary
  • anesthesia is accomplished in approximately 20 seconds
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: consult a dentist or doctor

Inactive ingredients

flavor, hydrocarbon propellant (isobutane and propane), polyethylene glycol, sodium saccharin

Questions or comments?

1-800-238-8542 or 1-847-473-1100

M-F: 8:00 a.m. - 4:00 p.m. CT

Principal Display Panel

NDC 0283-0679-02

HURRICIANE®

Topical Anesthetic Spray

20% Benzocaine Oral Anesthetic

ORIGINAL Wild Cherry

Manufactured for:

Beutlich® LP,

Pharmaceuticals

Since 1954

Waukegan, IL 60085

1/2 SECOND SPRAY is all you need!

Net Weight

2 oz. (59.7 g.)

DOT2Q  M5655

image of label

HURRICAINE  TOPICAL ANESTHETIC SPRAY
benzocaine spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0283-0679
Route of AdministrationORAL, DENTAL, PERIODONTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (Aminobenzoic Acid) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polyethylene Glycol 400 
Saccharin Sodium 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0283-0679-0259.7 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/1979
Labeler - Beutlich LP, Pharmaceuticals (005209325)

Revised: 7/2009
 
Beutlich LP, Pharmaceuticals

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