PC Gel 1oz

Manufacturer
Beutlich Pharmaceuticals, LLC | Dental Technologies, Inc. | Speciality Pharma Manufacturing
Effective date
2025-01-08
Label type
HUMAN OTC DRUG LABEL
Version
25
Source
full-release
Hydrated at
2026-06-01 00:51:42

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

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 imprinted seal under cap is broken or missing
• 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

Storage and Handling

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. to 4:30 p.m. ET

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0283-0886-31

1oz carton image1oz carton image
HURRICAINE®

Topical Anesthetic GEL

20% Benzocaine Oral Anesthetic

PINA COLADA

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN25
996288HurriCaine 20 % Oral GelPSN25
996288benzocaine 0.2 MG/MG Oral Gel [Hurricaine]SBD25
238910benzocaine 0.2 MG/MG Oral GelSCD25
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY25
996288Hurricaine 0.2 MG/MG Oral GelSY25
996288Hurricaine 20 % Dental GelSY25

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-0886-31HurriCaineTopical Anesthetic Gel28.4 g in 1 BOTTLE, PLASTICGEL28.425
0283-0886-43HurriCaineTopical Anesthetic Gel1 g in 1 PACKETGEL125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0283-0886HURRICAINE TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]25Current NDC, Legacy NDC, 2 package rows20250110_fef1f48c-e89d-4b75-9ba0-b1b068daf582.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0283-0886-31GM - Gram0283-08862edc4b3c-a2da-4c70-8d3a-05e6e0f03ecd12012-07-24
0283-0886-45EA - Each0283-0886937025f2-6b1b-4aee-a264-f789130a09aa12022-03-09
0283-0886-59EA - Each0283-0886fba5e691-828e-48d3-b412-cbb51a94ac1b12022-03-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BenzocaineACTIVE INGREDIENTU3RSY48JW55
BenzocaineACTIVE MOIETYU3RSY48JW55
Polyethylene Glycol 3350INACTIVE INGREDIENTG2M7P15E5P5
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQ5
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TY5

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
0283-08860283-0886-31, 0283-0886-43

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 102 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+dosage form
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, ORALLY DISINTEGRATING / ORAL0.16 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSYRUP / ORAL740 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, ORALLY DISINTEGRATING / ORAL0.16 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, CHEWABLE / ORAL15 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, CHEWABLE / ORAL15 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+dosage form
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / ORAL900 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, DELAYED RELEASE / ORAL26 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET / ORAL193 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE / ORAL576 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION, EXTENDED RELEASE / ORAL37 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, DELAYED RELEASE / ORAL26 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / VAGINAL1250 mgExact identifier — unii+dosage form
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, EXTENDED RELEASE / ORAL61 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, LIQUID FILLED / ORAL1122 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, DELAYED RELEASE / ORAL26 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PSUSPENSION / ORAL900 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION, CONCENTRATE / ORAL2813 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, EXTENDED RELEASE / ORAL60 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCONCENTRATE / ORAL3000 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, COATED / ORAL0.5 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE, EXTENDED RELEASE / ORAL17 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, ORALLY DISINTEGRATING / ORAL0.16 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED / ORAL20 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii+dosage form
66 equally ranked IID candidates
Saccharin SodiumSACCHARIN SODIUMSB8ZUX40TYGEL / DENTAL0.3 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQCAPSULE / ORAL13440 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PTABLET, DELAYED RELEASE / ORAL10 mgExact identifier — unii+route
33 equally ranked IID candidates
Polyethylene Glycol 400POLYETHYLENE GLYCOL 400B697894SGQFILM, SOLUBLE / ORAL29 mgExact identifier — unii+route
66 equally ranked IID candidates
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCAPSULE, EXTENDED RELEASE / ORAL51 mgExact identifier — unii+route
33 equally ranked IID candidates

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLC4c278122-2643-46bf-9e44-11985210a16e2025-11-06WarningsExact identifier
ndc (product): 0283-0886
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCfef1f48c-e89d-4b75-9ba0-b1b068daf5822025-01-08WarningsExact identifier
ndc (package): 0283-0886-43
ndc (package): 0283-0886-31
ndc (product): 0283-0886
ndc11 (package): 00283088631
ndc11 (package): 00283088643
spl id: 2b373b9e-eda7-72e5-e063-6394a90abf5e
spl set id: fef1f48c-e89d-4b75-9ba0-b1b068daf582

Reported adverse events (FAERS/openFDA)#

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