FDA.reportPublic FDA data

Alocane

Manufacturer
Quest Products, Inc. | Fill Tech USA
Effective date
2013-06-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:37:39

Label at a glance#

ProductAlocane
Active ingredientLidocaine Hydrochloride
Label structure10 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

Store in a cool, dry area.

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 Burns, Insect Bites and minor Skin Irritation, Cuts and Scrapes.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

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

Adults and children 2 years of age or older

SPL UNCLASSIFIED SECTION

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

Other Information

STORAGE AND HANDLING SECTION

Store in a cool, dry area.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
Quest Products, Inc. Gurnee, IL 60031

PRINCIPAL DISPLAY PANEL - 75 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4% Lidocaine
Maximum Strength

USED IN HOSPITALS
BURN CENTERS

MAXIMUM STRENGTH

ALOCANE®

Emergency Burn Gel

  • Fast Pain and Itch Relief
  • Assists the Healing Process
  • Soothing Aloe Gel & Vitamin E
  • Use on Sunburns and First Degree Burns

Recommended by
Physicians and Pharmacists

Aloe
BRAZILIAN

MADE IN THE
USA

Net Wt 2.5 fl. oz
(75ml)

Principal Display Panel - 75 mL Tube Carton
Principal Display Panel - 75 mL Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68229-200-022022-02-25C16284748780-19d75b9d0-fa6c-f424-e053-dadaa90a57ceAlocane ®
68229-200-022020-01-31C16284748780-19d75b9d0-fa6c-f424-e053-dadaa90a57ceAlocane ®

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68229-200-02ML - Milliliter68229-200f4837df7-1556-4272-809d-9dcd8c0f7bbe12017-09-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Lidocaine HydrochlorideACTIVE INGREDIENTV13007Z41A1
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 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68229-20068229-200-01, 68229-200-02

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

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 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SCREAM / TOPICAL15 %w/wExact identifier — unii candidate
2 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
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
Dimethyl IsosorbideDIMETHYL ISOSORBIDESA6A6V432SAEROSOL, FOAM / TOPICAL5.44 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d8db9210-d732-b9e4-e053-2a95a90a79fec08e418e-12a8-44c7-b448-7b1514a89f332022-02-25WarningsExact identifier
spl set id: c08e418e-12a8-44c7-b448-7b1514a89f33

Reported adverse events (FAERS/openFDA)#

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