FDA.reportPublic FDA data

Walgreens Max Strength Burn Gel

Manufacturer
Walgreens Co.
Effective date
2025-04-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:14:48

Label at a glance#

ProductWalgreens Max Strength Burn Gel
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

First aid to help prevent bacterial contamination 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 & older: Clean the affected area. Apply a small amount of gel on the affected area 1 to 3 times daily. May be covered with a sterile bandage (let dry first). cover with adhesive bandage or sterile gauze if needed apply 1 to 3 times daily. Children under 2 years of age: ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Cl 0.13%

Lidocaine HCI 4%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Topical pain relief

Uses:

INDICATIONS & USAGE SECTION

First aid to help prevent bacterial contamination 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

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • Deep or puncture wounds
  • Animal bite
  • Serious burns

Do not use:

OTC - DO NOT USE SECTION

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

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

KEEP OUT OF REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age & older:

  • Clean the affected area. Apply a small amount of gel on the affected area 1 to 3 times daily.
  • May be covered with a sterile bandage (let dry first).
  • cover with adhesive bandage or sterile gauze if needed
  • apply 1 to 3 times daily.

Children under 2 years of age:

  • ask a doctor

Other information:

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-9654-10Walgreens Max Strength Burn Gel1 in 1 CARTONGEL14
0363-9654-10Walgreens Max Strength Burn Gel75 mL in 1 TUBEGEL754

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-96540363-9654-10

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
ALOE VERA LEAF JUICERUE8E6T4NBIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CHLORPHENESINI670DAL4SZIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPANEDIOL5965N8W85TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
Walgreens Max Strength Burn GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWalgreens Co.25a1e89b-bafd-4770-e063-6294a90a14d22025-04-07WarningsExact identifier
ndc (package): 0363-9654-10
ndc (product): 0363-9654
ndc11 (package): 00363965410
spl id: 326d3a8e-cdcd-8da7-e063-6394a90a65a2
spl set id: 25a1e89b-bafd-4770-e063-6294a90a14d2

Reported adverse events (FAERS/openFDA)#

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