FDA.reportPublic FDA data

HurriCaine One

Manufacturer
Beutlich Pharmaceuticals LLC | Beutlich Pharmaceuticals, LLC
Effective date
2025-12-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:22:11

Label at a glance#

ProductHurriCaine One
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

Uses: For the temporary relief of pain First aid to help protect against infection in minor cuts, scrapes, and burns

Dosage and administration

do not exceed recommended dosage adults and children 2 years of age and older: Clean the affected area. Spray a small amount of this product on the area 1 to 3 times dally. May be covered wtth a sterile bandage. If bandaged, let dry first. children under 2 years of age: do not use, consult a physician

Storage and handling

store at 15-30 °C (59-86 °F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic/Analgesic

Topical First-Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

Uses:

  • For the temporary relief of pain
  • First aid to help protect against infection in minor cuts, scrapes, and burns

Warnings

WARNINGS SECTION

  • For external use only. Do not use In the eyes or apply over large areas of the body, particularly over raw sur1aces or blistered areas. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.
  • If condition worsens, or If symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use longer than 1 week unless directed by a doctor.
  • Flammable. Keep away from fire or flame.

Do not use

OTC - STOP USE SECTION

Do not Use

  • if foil pouch has been previously opened
  • 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 accidently swallowed, get medical help or contact a Poison Control Center Immediately

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not exceed recommended dosage

adults and children 2 years of age and older: Clean the affected area. Spray a small amount of this product on the area 1 to 3 times dally. May be covered wtth a sterile bandage. If bandaged, let dry first.

children under 2 years of age: do not use, consult a physician

Other information

STORAGE AND HANDLING SECTION

  • store at 15-30 °C (59-86 °F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Polyethylene glycol, Ethanol

Questions or comments?

OTC - QUESTIONS SECTION

1-800-238-4582

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HC1 - Lidocaine 2ct boxHC1 - Lidocaine 2ct box

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HC1 - Lidocaine 25ct boxHC1 - Lidocaine 25ct box

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0283-1024-11HurriCaine One2 in 1 BOXSPRAY21
0283-1024-26HurriCaine One25 in 1 BOXSPRAY251
0283-1024-43HurriCaine One0.37 g in 1 APPLICATORSPRAY0.371

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0283-10240283-1024-43, 0283-1024-11, 0283-1024-26

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
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
ALCOHOL3K9958V90MIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HurriCaine OneTOPICAL ANESTHETIC AND ANTISEPTICBeutlich Pharmaceuticals LLC459cedbd-9b6f-e450-e063-6394a90afb732025-12-10WarningsExact identifier
ndc (package): 0283-1024-43
ndc (package): 0283-1024-11
ndc (package): 0283-1024-26
ndc (product): 0283-1024
ndc11 (package): 00283102426
ndc11 (package): 00283102443
ndc11 (package): 00283102411
spl id: 459cf910-f9f8-d93f-e063-6394a90a8789
spl set id: 459cedbd-9b6f-e450-e063-6394a90afb73

Reported adverse events (FAERS/openFDA)#

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