HURRICAINE TOPICAL ANESTHETIC- benzocaine gel

HurriCaine by

Drug Labeling and Warnings

HurriCaine by is a Otc medication manufactured, distributed, or labeled by Beutlich Pharmaceuticals LLC, Dental Technologies, Centrix Inc., Beutlich Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingedient

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

Allergy alert: ​Do not use if you have a history of allergy to local anesthetics such as procaine, butaine, benzocaine or other "caine" anesthetics.

Stop use and ask doctor if

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

DO NOT USE:

• if the product film is punctured or damaged

• for teething

• in children under 2 years of age

When using this product

• avoid contact with eyes

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.

Adverse Reactions:

Methemoglobinemia has been reported following the use of benzocaine on extremely rare occasions. Intravenous methylene blue is the specific therapy for this condition.

Directions

• do not exceed recommend 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: consult a dentist or doctor

Other information

• do not use if imprinted seal under cap is broken or missing
• store at 20-25 °C (68-77 °F)

Inactive ingredient

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

HurriCaine Unit Dose Gel Mint 0.5g with Swab: 0283-0998-45

60ct HurriCaine Unit Dose Gel Mint 0.5g with Swab: 0283-0998-59

INGREDIENTS AND APPEARANCE

HURRICAINE  TOPICAL ANESTHETIC
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0283-0998
Route of Administration	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	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0283-0998-59	60 in 1 BOX	01/31/2021
1	NDC: 0283-0998-45	0.5 g in 1 CUP, UNIT-DOSE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	09/15/1998

Labeler - Beutlich Pharmaceuticals LLC (005209325)

Registrant - Beutlich Pharmaceuticals LLC (005209325)

Establishment
Name	Address	ID/FEI	Business Operations
Beutlich Pharmaceuticals, LLC		005209325	label(0283-0998) , pack(0283-0998)

Establishment
Name	Address	ID/FEI	Business Operations
Centrix Inc.		053707303	label(0283-0998)

Establishment
Name	Address	ID/FEI	Business Operations
Dental Technologies		148312838	manufacture(0283-0998)