Label at a glance#

ProductHurriCaine Topical Anesthetic

Active ingredientBENZOCAINE

Label structure12 sections

Indications and 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

Dosage and administration

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)

Contacts and useful links#

PhoneLabel contact1-800-238-8542

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - STOP USE SECTION

Do not use:

if the product film is punctured or damaged

for teething

in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

store at 20°-25° C (68°-77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, polyethylene glycol, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-238-8542

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HurriCaine Unit Dose Gel - Wild Cherry

HurriCaine Unit Dose Gel Wild Cherry 0.5g with Swab: 0283-0871-45

60ct HurriCaine Unit Dose Gel Wild Cherry 0.5g with Swab: 0283-0871-59

60ct HurriCaine Unit Dose Gel Box - Wild Cherry

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
238910	benzocaine 20 % Oral Gel	PSN	26
996288	HurriCaine 20 % Oral Gel	PSN	26
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	26
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	26
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	26
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	26
996288	Hurricaine 20 % Dental Gel	SY	26

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BENZOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0283-0871-59	2023-02-01	C162847	48780-1	f386c649-f23d-0266-e053-dadaa90a7c1a	HurriCaine Unit Dose Gel and Swab - Cherry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0283-0871-45	HurriCaineTopical Anesthetic	0.5 g in 1 CUP, UNIT-DOSE	GEL	0.5		26
0283-0871-59	HurriCaineTopical Anesthetic	60 in 1 BOX	GEL	60		26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0283-0871	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	26	Current NDC, Legacy NDC, 2 package rows	20250110_e628bd9f-99e5-4c71-ba8a-caa6c337de54.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0283-0871-12	GM - Gram	0283-0871	6691d8d3-e365-4b3c-ac65-03bdf46d01f6	1	2012-07-24
0283-0871-31	GM - Gram	0283-0871	13270ff7-44c9-4115-bc6e-688a24f23ac5	1	2012-07-24
0283-0871-45	EA - Each	0283-0871	7e35be3f-eaad-4633-ae1f-b5241f285920	1	2022-03-09
0283-0871-59	EA - Each	0283-0871	4ee3acb3-dc3a-4da0-8528-b4c60fc376b5	1	2022-03-09
0283-0871-75	GM - Gram	0283-0871	2f16edc3-01b9-467d-b7e6-941c9305aff4	1	2012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

HurriCaine Topical Anesthetic
Benzocaine
POLYETHYLENE GLYCOL 400
POLYETHYLENE GLYCOL 3350
SACCHARIN SODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0283-0871	0283-0871-45, 0283-0871-59

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
POLYETHYLENE GLYCOL 3350	G2M7P15E5P	IACT
SACCHARIN SODIUM	SB8ZUX40TY	IACT
BENZOCAINE	U3RSY48JW5	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	113cdb83-0fdd-40f2-8ee6-b771dca99713	2025-08-12	Warnings	Exact identifier ndc (product): 0283-0871
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	e628bd9f-99e5-4c71-ba8a-caa6c337de54	2025-01-08	Warnings	Exact identifier ndc (package): 0283-0871-45 ndc (package): 0283-0871-59 ndc (product): 0283-0871 ndc11 (package): 00283087159 ndc11 (package): 00283087145 spl id: 2b36d55e-dff3-76cc-e063-6294a90a76ef spl set id: e628bd9f-99e5-4c71-ba8a-caa6c337de54
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	1f3d68f6-afd6-42e7-b3e5-210228c8e7de	2024-10-28	Warnings	Exact identifier ndc (product): 0283-0871

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

HurriCaine Unit Dose Gel and Swab - Cherry