FDA.reportPublic FDA data

Alocane Plus

Manufacturer
Quest Products, Inc. | Fill Tech USA
Effective date
2025-07-17
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:07:40

Label at a glance#

ProductAlocane Plus
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

Apply to affected area not more than 3 to 4 times daily. Do not use in large quantities, particularly over raw surfaces or blistered areas. Children under 2 years of age, consult a physician.

Storage and handling

Store at Room Temperature of 15° - 30°C (59° - 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Lidocaine HCL 4%Topical Analgesic
Benzalkonium Chloride 0.13%Topical Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

SPL UNCLASSIFIED SECTION

Apply to affected area not more than 3 to 4 times daily. Do not use in large quantities, particularly over raw surfaces or blistered areas.

Children under 2 years of age, consult a physician.

Other Information

STORAGE AND HANDLING SECTION

Store at Room Temperature of 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 - 59 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2587646ALOCANE plus 4 % / 0.13 % Topical GelPSN10
2375042benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % Topical GelPSN10
2587646benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical Gel [Alocane Plus]SBD10
2375042benzalkonium chloride 0.0013 MG/MG / lidocaine hydrochloride 0.04 MG/MG Topical GelSCD10
2587646Alocane Plus (benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % ) Topical GelSY10
2375042benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % Topical GelSY10

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68229-300-022020-02-03C16284748780-19d75b9d1-2b47-f424-e053-dadaa90a57ceAlocane ® Plus
68229-300-022020-01-31C16284748780-19d75b9d1-2b47-f424-e053-dadaa90a57ceAlocane ® Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-300-01Alocane Plus3.55 mL in 1 DOSE PACKGEL3.5510
68229-300-02Alocane Plus50 in 1 BOXGEL5010
68229-300-03Alocane Plus1 in 1 CARTONGEL110
68229-300-03Alocane Plus59 mL in 1 TUBEGEL5910
68229-300-04Alocane Plus946 mL in 1 BOTTLE, PUMPGEL94610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-300-01EA - Each68229-300379cbe87-939f-4066-8e28-789c4c3430db12021-01-08
68229-300-02EA - Each68229-300b520af95-ef09-4734-9392-dcb3d85fe98112021-01-08
68229-300-03ML - Milliliter68229-30027207190-a638-4f5a-b3df-27cde1c29d3b12021-09-07
68229-300-04ML - Milliliter68229-30074748392-6b14-42fc-8c52-9340ed8a8bb312021-09-07
68229-300-05ML - Milliliter68229-300e75b92b2-0797-472a-8c2e-1f676e76b8ff22022-02-07
68229-300-06ML - Milliliter68229-300110ad54a-6f0b-4007-9433-4a41ec8d354322022-02-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W71
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41A1
BenzalkoniumACTIVE MOIETY7N6JUD5X6Y1
LidocaineACTIVE MOIETY98PI2009871
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X1
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
ChlorphenesinINACTIVE INGREDIENTI670DAL4SZ1
Dimethyl IsosorbideINACTIVE INGREDIENTSA6A6V432S1
Hydroxyethyl Cellulose (5500 MPA.S AT 2%)INACTIVE INGREDIENTM825OX60H91
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
PropanediolINACTIVE INGREDIENT5965N8W85T1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68229-30068229-300-01, 68229-300-02, 68229-300-03, 68229-300-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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 1 · 35 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
15 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SCREAM / TOPICAL15 %w/wExact identifier — unii+route
10 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SAEROSOL, FOAM / TOPICAL5.44 %w/wExact identifier — unii+route
10 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SCREAM / TOPICAL15 %w/wExact identifier — unii+route
10 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SCREAM / TOPICAL15 %w/wExact identifier — unii+route
10 equally ranked IID candidates
Hydroxyethyl Cellulose (5500 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)M825OX60H9TABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
5 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SCREAM / TOPICAL15 %w/wExact identifier — unii+route
10 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SAEROSOL, FOAM / TOPICAL5.44 %w/wExact identifier — unii+route
10 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
15 equally ranked IID candidates
Hydroxyethyl Cellulose (5500 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)M825OX60H9TABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
5 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
15 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
15 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
15 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SCREAM / TOPICAL15 %w/wExact identifier — unii+route
10 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
15 equally ranked IID candidates
Hydroxyethyl Cellulose (5500 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)M825OX60H9TABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
5 equally ranked IID candidates
Hydroxyethyl Cellulose (5500 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)M825OX60H9TABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
5 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
15 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
15 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
15 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SAEROSOL, FOAM / TOPICAL5.44 %w/wExact identifier — unii+route
10 equally ranked IID candidates
Hydroxyethyl Cellulose (5500 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (5500 MPA.S AT 2%)M825OX60H9TABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
5 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
15 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
15 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SAEROSOL, FOAM / TOPICAL5.44 %w/wExact identifier — unii+route
10 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SAEROSOL, FOAM / TOPICAL5.44 %w/wExact identifier — unii+route
10 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
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLCb3ec09b9-7511-0895-e053-2a95a90a78402025-12-04WarningsExact identifier
ndc (product): 68229-300
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.24538037-1d74-48a0-b909-98ecc57651fe2025-07-17WarningsExact identifier
ndc (package): 68229-300-01
ndc (package): 68229-300-03
ndc (package): 68229-300-02
ndc (package): 68229-300-04
ndc (product): 68229-300
ndc11 (package): 68229030002
ndc11 (package): 68229030001
ndc11 (package): 68229030004
ndc11 (package): 68229030003
spl id: 3a24dd33-2000-ccc2-e063-6394a90a8f13
spl set id: 24538037-1d74-48a0-b909-98ecc57651fe

Reported adverse events (FAERS/openFDA)#

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