HURRICAINE TOPICAL ANESTHETIC GEL- benzocaine gel

Drug Labeling and Warnings

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 procedures
• 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.

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
if imprinted seal under cap is broken or missing
for teething
in children under 2 years of age      

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:
do not exceed recommended dosage

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

Storage and Handling

• store at 20°-25°C (68°-77°F)

Inactive ingredients

flavor, polyethylene glycol, sodium saccharin

Questions or comments?

1-800-238-8542

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

Principal Display Panel

NDC: 0283-0886-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

PINA COLADA

Manufactured for:
Beutlich® Pharmaceuticals LLC
Bunnell, FL 32110
Made in the USA
1 oz.

INGREDIENTS AND APPEARANCE

HURRICAINE  TOPICAL ANESTHETIC GEL
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0283-0886
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)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
Saccharin Sodium (UNII: SB8ZUX40TY)

Product Characteristics
Color	yellow (yellow to pale orange)	Score
Shape		Size
Flavor	COCONUT (Pina Colada Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0283-0886-31	28.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/15/1986
2	NDC: 0283-0886-43	1 g in 1 PACKET; Type 0: Not a Combination Product	01/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	08/15/1986

Labeler - Beutlich Pharmaceuticals, LLC (005209325)

Registrant - Beutlich Pharmaceuticals, LLC (005209325)

Establishment
Name	Address	ID/FEI	Business Operations
Dental Technologies, Inc.		148312838	manufacture(0283-0886)

Establishment
Name	Address	ID/FEI	Business Operations
Speciality Pharma Manufacturing		013957125	manufacture(0283-0886)