FDA.reportPublic FDA data

Alocane

Manufacturer
Quest Products, Inc. | Fill Tech USA
Effective date
2026-10-22
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
daily-update
Hydrated at
2026-10-27 02:03:54

Label at a glance#

ProductAlocane Emergency Burn Pads
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

For the temporary relief of pain and itching associated with: Sunburn Minor Bums Minor Skin Irritation Cuts & Scrapes Insect Bites

Dosage and administration

Clean the burn area with mild soap and water. Gently apply the Alocane• Pad over the burn or wound. Use on affected area not more than 3 to 4 times daily Children under 2 years of age consult a doctor.

Storage and handling

Store at room temperature 15-30ºC (59-86ºF)

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 Bums
  • Minor Skin Irritation
  • 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.

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED SECTION

  • Clean the burn area with mild soap and water.
  • Gently apply the Alocane• Pad over the 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 15-30ºC (59-86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PRINCIPAL DISPLAY PANEL - 10 Pad Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68229-403-022020-02-03C16284748780-19d75b9d0-8239-f424-e053-dadaa90a57ceAlocane ® Emergency Burn Pads
68229-403-022020-02-03C16284748780-19d75b9d0-8239-f424-e053-dadaa90a57ceAlocane ® Emergency Burn Pads
68229-403-022020-01-31C16284748780-19d75b9d0-8239-f424-e053-dadaa90a57ceAlocane ® Emergency Burn Pads
68229-403-022020-01-31C16284748780-19d75b9d0-8239-f424-e053-dadaa90a57ceAlocane ® Emergency Burn Pads

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
68229-40368229-403-01, 68229-403-02, 68229-403-03

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
CHLORPHENESINI670DAL4SZIACT
CAPRYLYL GLYCOL00YIU5438UIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-11-05full-release2026-06-01 00:34:36

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
262ef610-18a7-1bbb-e063-6394a90a5c10fe58bb89-7216-4121-afd3-d1438bdfbfa22024-11-05WarningsExact identifier
spl set id: fe58bb89-7216-4121-afd3-d1438bdfbfa2

Reported adverse events (FAERS/openFDA)#

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