FDA.reportPublic FDA data

Alocane ® Emergency Burn Gel

Manufacturer
Quest Products, LLC. | Fill Tech USA
Effective date
2026-10-22
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
daily-update
Hydrated at
2026-10-27 02:03:05

Label at a glance#

ProductAlocane Emergency Burn
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

For the temporary relief of pain and itching associated with: Sunburn Minor Skin Irritation Minor Burns Cuts & Scrapes Insect Bites

Storage and handling

Store at room temperature 15-30°C (59-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with:

  • Sunburn
  • Minor Skin Irritation
  • Minor Burns
  • Cuts & Scrapes
  • Insect Bites

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask doctor: if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health care professional before use.

DOSAGE & ADMINISTRATION SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and Children 2 years of age or older:

  • Clean the burn area with mild soap and water
  • Gently apply over bthe burn or wound
  • Use on affected area not more than 3 to 4 times daily

Children under 2 years of age: Consult a doctor

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 15-30°C (59-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

1,3-Propanediol, Aloe Barbadensis (Aloe) Leaf Juice, Caprylyl Glycol, Chlorphenesin, Dimethyl Isosorbide, Hydroxyethyl Cellulose, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Water.

SPL UNCLASSIFIED SECTION

Distributed by:

Quest Products, LLC.

Pleasant Prairie, WI 53158

PRINCIPAL DISPLAY PANEL - ALOCANE Burn Gel 2.5 fl oz tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

201-02201-02

PRINCIPAL DISPLAY PANEL -- ALOCANE Burn Gel Pump

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

201-14201-14

PRINCIPAL DISPLAY PANEL - ALOCANE Burn Gel Single Use 45 Count

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

45SingleUse45SingleUse

PRINCIPAL DISPLAY PANEL - ALOCANE Burn Spray 3.5 fl oz

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

201.08201.08

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codealocane.com/201-08.jpg

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

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68229-20168229-201-01, 68229-201-02, 68229-201-03, 68229-201-04, 68229-201-05, 68229-201-06, 68229-201-07, 68229-201-08, 68229-201-11, 68229-201-09, 68229-201-10, 68229-201-14, 68229-201-15, 68229-201-12, 68229-201-13, 68229-201-17, 68229-201-18, 68229-201-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
PROPANEDIOL5965N8W85TIACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)M825OX60H9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
142024-11-05full-release2026-06-01 00:34:17

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
262e0e1d-21b6-be5e-e063-6394a90ab0aa0c8e65a6-dff3-43b4-a3f1-95deb574ea892024-11-05WarningsExact identifier
spl set id: 0c8e65a6-dff3-43b4-a3f1-95deb574ea89

Reported adverse events (FAERS/openFDA)#

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