FDA.reportPublic FDA data

Alocane ® Max Spray

Manufacturer
Quest Products LLC | Filltech USA, LLC
Effective date
2025-12-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:19:37

Label at a glance#

ProductAlocane Max
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

First aid to help prevent bacterial icontamination or skin infection, and for temporary relief of pain and itching associated with minor: Burns Cuts Sunburn Scrapes Minor Skin Irritation

Dosage and administration

Adults and children 2 years of age and older: Clean the affected area. Spray a small amount on the affected area 3 to 4 times daily. May be covered with a sterile bandage (let dry first). To apply to the face, spray on palm and apply. Children under 2 years of age: ask a doctor.

Storage and handling

Store at 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

Benzalkonium Chloride 0.13%

Lidocaine HCL 4%

First Aid Antiseptic

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

First aid to help prevent bacterial icontamination or skin infection, and for temporary relief of pain and itching associated with minor:

  • Burns
  • Cuts
  • Sunburn
  • Scrapes
  • Minor Skin Irritation

Warnings

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

  • Deep or puncture wounds
  • Animal Bites
  • Serious burns

OTC - DO NOT USE SECTION

Do not use:

  • In or near the eyes
  • In large quantities or over large areas of the body
  • On raw surfaces or blistered areas

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Clean the affected area. Spray a small amount on the affected area 3 to 4 times daily. May be covered with a sterile bandage (let dry first). To apply to the face, spray on palm and apply.

Children under 2 years of age: ask a doctor.

Other Information

STORAGE AND HANDLING SECTION

Store at 15°-30°C (59°-86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 3.5 fl oz spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2477939Alocane Max Strength 4 % / 0.13 % Topical SprayPSN3
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SprayPSN3
2477939benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical Spray [Alocane Max Strength]SBD3
2047877benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 40 MG/ML Topical SpraySCD3
2477939Alocane Max Strength (benzalkonium chloride 0.13 % / lidocaine hydrochloride 4 % ) Topical SpraySY3
2047877benzalkonium chloride 0.13 % / lidocaine HCl 4 % Topical SpraySY3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130846241032581GTIN-13: 0846241032581
EAN-13: 0846241032581
GTIN-12: 846241032581
UPC-A: 846241032581
GTIN storage (14 digits): 00846241032581		Alocane_Max_Spray.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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-408-01Alocane Max104 mL in 1 BOTTLE, SPRAYSPRAY1043
68229-408-02Alocane Max118 mL in 1 BOTTLE, SPRAYSPRAY1183
68229-408-03Alocane Max124 mL in 1 BOTTLE, SPRAYSPRAY1243

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-408-01ML - Milliliter68229-408c2464e38-427d-402d-b547-7b902258814f12023-12-05

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
68229-40868229-408-01, 68229-408-02, 68229-408-03

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

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 MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35221a-2fcb-2735-e063-6294a90a88ca2025-12-04WarningsExact identifier
ndc (package): 68229-408-02
ndc (package): 68229-408-03
ndc (package): 68229-408-01
ndc (product): 68229-408
ndc11 (package): 68229040802
ndc11 (package): 68229040801
ndc11 (package): 68229040803
spl id: 4526c253-b573-1d84-e063-6394a90ae3f9
spl set id: 0a35221a-2fcb-2735-e063-6294a90a88ca

Reported adverse events (FAERS/openFDA)#

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