FDA.reportPublic FDA data

Alocane Plus

Manufacturer
Quest Products, Inc. | Fill Tech USA
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:34:33

Label at a glance#

ProductAlocane Plus
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

First Aid to help prevent bacterial infection associated with contamination of the skin. Temporarily relieves pain and itching due to: minor cuts scrapes minor burns

Dosage and administration

Adults and children 2 years of age or older: Shake well Clean the affected area Spray on the affected area 1 to 3 times daily May be covered with a sterile bandage after drying Children under 2 years of age: consult a doctor

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Lidocaine HCl 4.0%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

First Aid to help prevent bacterial infection associated with contamination of the skin. Temporarily relieves pain and itching due to:

  • minor cuts
  • scrapes
  • 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. 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.

Stop Use and ask doctor

OTC - STOP USE SECTION

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

Do not use:

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas.

If pregnant or breast-feeding

PREGNANCY SECTION

ask a health care professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age or older:

  • Shake well
  • Clean the affected area
  • Spray on the affected area 1 to 3 times daily
  • May be covered with a sterile bandage after drying

Children under 2 years of age: consult a doctor

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.

PRINCIPAL DISPLAY PANEL - 3.5 fl oz Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68229-404-01Alocane Plus104 mL in 1 BOTTLE, SPRAYGEL1044

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68229-404ALOCANE PLUS (LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE) GEL [QUEST PRODUCTS, INC.]4Current NDC, Legacy NDC, 1 package rows20241107_cfe8114b-df65-064b-e053-2a95a90a33f6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-404-01ML - Milliliter68229-404078685c3-e09b-4d18-b038-40dd6a122d3212024-05-16

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
68229-40468229-404-01

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 PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.cfe8114b-df65-064b-e053-2a95a90a33f62024-11-05WarningsExact identifier
ndc (package): 68229-404-01
ndc (product): 68229-404
ndc11 (package): 68229040401
spl id: 262e23fb-5ad9-bbde-e063-6394a90ab37b
spl set id: cfe8114b-df65-064b-e053-2a95a90a33f6

Reported adverse events (FAERS/openFDA)#

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