HurriCaine

Manufacturer
Beutlich Pharmaceuticals, LLC | Dental Technologies Inc.
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:51:39

Label at a glance#

ProductHurriCaine Topical Anesthetic Gel
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

Other information store at 20°-25° C (68°- 77° F)

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 product film is punctured or damaged
• for teething
• in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

When using this product: avoid contact with eyes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

Other information
store at 20°-25° C (68°- 77° F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

flavor, polyethylene glycol, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

1-800-238-8542

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

unit dose Watermelonunit dose Watermelon

HurriCaine Unit Dose Gel Watermelon 0.5g with Swab: 0283-0293-45

60ct HurriCaine Unit Dose Gel Watermelon 0.5g with Swab: 0283-0293-59

60ct unit dose gel Watermelon60ct unit dose gel Watermelon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN5
996288HurriCaine 20 % Oral GelPSN5
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD5
238910benzocaine 0.2 MG/MG Oral GelSCD5
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY5
996288Hurricaine 0.2 MG/MG Oral GelSY5
996288Hurricaine 20 % Dental GelSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-0293-45HurriCaineTopical Anesthetic Gel0.5 g in 1 CUP, UNIT-DOSEGEL0.55
0283-0293-53HurriCaineTopical Anesthetic Gel60 in 1 BOXGEL605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0293HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]5Current NDC, Legacy NDC, 2 package rows20250110_e67b8def-c728-4952-9b35-874643cbe0f1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0293-31GM - Gram0283-029398d97e9b-95bd-43e2-b5cf-bf5d3dea299612012-07-24
0283-0293-45EA - Each0283-0293db753360-afca-4d14-b286-665de8ff5c2b12022-03-09
0283-0293-59EA - Each0283-0293411efd25-85d0-4258-85c0-6ddd8377461912022-03-09

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0283-02930283-0293-45, 0283-0293-53

Ingredients#

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

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

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC106b6115-d043-4050-80c6-1d82456dea022025-11-06WarningsExact identifier
ndc (package): 0283-0293-45
ndc (product): 0283-0293
ndc11 (package): 00283029345
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCe67b8def-c728-4952-9b35-874643cbe0f12025-01-08WarningsExact identifier
ndc (package): 0283-0293-53
ndc (package): 0283-0293-45
ndc (product): 0283-0293
ndc11 (package): 00283029345
ndc11 (package): 00283029353
spl id: 2b364db1-b3c2-9b01-e063-6294a90ac13b
spl set id: e67b8def-c728-4952-9b35-874643cbe0f1
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCc113773b-dfb0-4797-ae0e-ecc06bfffd682025-01-08WarningsExact identifier
ndc (product): 0283-0293

Reported adverse events (FAERS/openFDA)#

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