HURRICAINE TOPICAL ANESTHETIC- benzocaine gel
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 Gel - Cherry 1oz

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

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

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 irritation, pain, or redness persists or worsens

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.

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: 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 ingredients

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

NDC 0283-0871-31

HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

ORIGINAL WILD CHERRY

Manufactured for:

Beutlich® Pharmaceuticals, LLC

Bunnell, FL 32110

1 oz.

Principal Display

HURRICAINE TOPICAL ANESTHETIC
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0283-0871
Route of Administration	DENTAL, ORAL, PERIODONTAL

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

Ingredient Name	Strength
Inactive Ingredients
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Product Characteristics
Color	brown (amber)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0283-0871-31	1 in 1 BOX	08/15/1971
1		28.4 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/15/1971

Labeler - Beutlich Pharmaceuticals, LLC (005209325)

Registrant - Beutlich Pharmaceuticals, LLC (005209325)

Name	Address	ID/FEI	Business Operations
Establishment
Dental Technologies Inc.		148312838	manufacture(0283-0871)

Name	Address	ID/FEI	Business Operations
Establishment
SPECIALITY PHARMA MANUFACTURING, LLC		013957125	manufacture(0283-0871)

Revised: 1/2023

Document Id: 10e0d44c-1f32-487f-e054-00144ff88e88

Set id: 1f3d68f6-afd6-42e7-b3e5-210228c8e7de

Version: 23

Effective Time: 20230110

Beutlich Pharmaceuticals, LLC