FDA.reportPublic FDA data

Alocane ® Emergency Burn Gel

Manufacturer
Quest Products, LLC. | Fill Tech USA
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:34:17

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1875237Alocane 4 % Topical GelPSN14
1010077lidocaine HCl 4 % Topical GelPSN14
1875237lidocaine hydrochloride 0.04 MG/MG Topical Gel [Alocane]SBD14
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD14
1875237Alocane 0.04 MG/MG Topical GelSY14
1875237Alocane 4 % Topical GelSY14
1010077lidocaine hydrochloride 4 % Topical GelSY14

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
68229-201-01Alocane Emergency Burn110 mL in 1 TUBEGEL11014
68229-201-02Alocane Emergency Burn1 in 1 CARTONGEL114
68229-201-03Alocane Emergency Burn110 mL in 1 BOTTLE, SPRAYGEL11014
68229-201-04Alocane Emergency Burn3.4 mL in 1 PACKETGEL3.414
68229-201-05Alocane Emergency Burn24 in 1 CARTONGEL2414
68229-201-06Alocane Emergency Burn3.4 mL in 1 PACKETGEL3.414
68229-201-07Alocane Emergency Burn45 in 1 CARTONGEL4514
68229-201-08Alocane Emergency Burn103.507 mL in 1 BOTTLE, SPRAYGEL103.50714
68229-201-09Alocane Emergency Burn118.294 mL in 1 TUBEGEL118.29414
68229-201-10Alocane Emergency Burn1 in 1 CARTONGEL114
68229-201-11Alocane Emergency Burn133.081 mL in 1 BOTTLE, SPRAYGEL133.08114
68229-201-12Alocane Emergency Burn1 in 1 KITGEL114
68229-201-13Alocane Emergency Burn1 in 1 CARTONGEL114
68229-201-14Alocane Emergency Burn946 mL in 1 BOTTLE, PUMPGEL94614
68229-201-15Alocane Emergency Burn800 mL in 1 BAGGEL80014
68229-201-16Alocane Emergency Burn124 mL in 1 BOTTLE, SPRAYGEL12414
68229-201-17Alocane Emergency Burn22 mL in 1 TUBEGEL2214
68229-201-18Alocane Emergency Burn1 in 1 CARTONGEL114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-201ALOCANE EMERGENCY BURN (LIDOCAINE HYDROCHLORIDE) GEL [QUEST PRODUCTS, LLC.]14Current NDC, Legacy NDC, 18 package rows20241107_0c8e65a6-dff3-43b4-a3f1-95deb574ea89.zip

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

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
Alocane Emergency BurnLIDOCAINE HYDROCHLORIDEQuest Products, LLC.0c8e65a6-dff3-43b4-a3f1-95deb574ea892024-11-05WarningsExact identifier
ndc (package): 68229-201-02
ndc (package): 68229-201-13
ndc (package): 68229-201-03
ndc (package): 68229-201-06
ndc (package): 68229-201-14
ndc (package): 68229-201-04
ndc (package): 68229-201-12
ndc (package): 68229-201-08
ndc (package): 68229-201-07
ndc (package): 68229-201-10
ndc (package): 68229-201-05
ndc (package): 68229-201-18
ndc (package): 68229-201-16
ndc (package): 68229-201-09
ndc (package): 68229-201-01
ndc (package): 68229-201-11
ndc (package): 68229-201-15
ndc (package): 68229-201-17
ndc (product): 68229-201
ndc11 (package): 68229020106
ndc11 (package): 68229020103
ndc11 (package): 68229020111
ndc11 (package): 68229020101
ndc11 (package): 68229020107
ndc11 (package): 68229020116
ndc11 (package): 68229020114
ndc11 (package): 68229020110
ndc11 (package): 68229020118
ndc11 (package): 68229020115
ndc11 (package): 68229020104
ndc11 (package): 68229020113
ndc11 (package): 68229020102
ndc11 (package): 68229020117
ndc11 (package): 68229020108
ndc11 (package): 68229020105
ndc11 (package): 68229020109
ndc11 (package): 68229020112
spl id: 262e0e1d-21b6-be5e-e063-6394a90ab0aa
spl set id: 0c8e65a6-dff3-43b4-a3f1-95deb574ea89

Reported adverse events (FAERS/openFDA)#

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