HURRICAINE TOPICAL ANESTHETIC- benzocaine spray

HurriCaine by

Drug Labeling and Warnings

HurriCaine by is a Otc medication manufactured, distributed, or labeled by Beutlich Pharmaceuticals, LLC, TRI-PAC INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 injury of the mouth and gums
• minor dental proedures
• minor irritation of the mouth and gums caused by dentures or orthodontic appliances

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.

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

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
for teething
in children under 2 years of age

When using this product

When using this product

• avoid spraying in 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

Directions:

• do not exceed recommended dosage
• firmly insert extension tube into spray can valve and ensure it fits securely into the actuator opening
• position the extension tube 1-2 inches from the 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: do not use

Inactive ingredients

flavor, hydrocarbon propellant (isobutane and propane), 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

Cool Mint Spray NDC: 0283-0914-02

INGREDIENTS AND APPEARANCE

HURRICAINE   TOPICAL ANESTHETIC
benzocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0283-0914
Route of Administration	ORAL, DENTAL, PERIODONTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MINT (UNII: FV98Z8GITP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0283-0914-02	59.7 g in 1 CAN; Type 0: Not a Combination Product	09/01/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	09/01/2014

Labeler - Beutlich Pharmaceuticals, LLC (005209325)

Registrant - Beutlich Pharmaceuticals, LLC (005209325)

Establishment
Name	Address	ID/FEI	Business Operations
Precise Packaging		079904428	manufacture(0283-0914)