FDA.reportPublic FDA data

CVS Burn Gel

Manufacturer
CVS Pharmacy | Weeks & Leo, Inc. | weeks & Leo
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:19:47

Label at a glance#

ProductCVS Maximum Strength Burn
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Dosage and administration

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor

Storage and handling

Store between 20 °C and 25 °C (68 °F and 77 °F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

In large quantities, particularly over raw surfaces or blistered areas

OTC - WHEN USING SECTION

Do not get into eyes

OTC - STOP USE SECTION

condition gets worse

symptoms last for more than 7 days

symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor

OTC - PURPOSE SECTION

topical analgesic

Other Information

STORAGE AND HANDLING SECTION

Store between 20 °C and 25 °C (68 °F and 77 °F)

INACTIVE INGREDIENT SECTION

Aloe barbadensis (aloe vera) leaf juice, caprylyl glycol, chlorphensin, dimethyl isosorbide, hydroxyethyl cellulose, phenoxyethanol, propanediol, purified water, vitamin E

RECENT MAJOR CHANGES SECTION

Uses: Removed title and removed

Directions: Added bullets to separate the requirement

OTC - QUESTIONS SECTION

call 515-276-1586

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health

Maximum Strength Burn Gel

Lidocaine HCl 4%

Topical Analgesic

  • Use on sunburns & minor burns
  • Past pain & itch relief
  • Soothing aloe & vitamin E

21-290-25v3.0 carton21-290-25v3.0 carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010077lidocaine HCl 4 % Topical GelPSN1
1010077lidocaine hydrochloride 0.04 MG/MG Topical GelSCD1
1010077lidocaine hydrochloride 4 % Topical GelSY1

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
69842-309-25CVS Maximum Strength Burn74 g in 1 TUBEGEL741
69842-309-25CVS Maximum Strength Burn1 in 1 CARTONGEL11

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-30969842-309-25

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
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPANEDIOL5965N8W85TIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
WATER059QF0KO0RIACT
CHLORPHENESINI670DAL4SZIACT

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
CVS Maximum Strength BurnLIDOCAINE HYDROCHLORIDE 4%CVS Pharmacy4510f379-c5a4-92c3-e063-6294a90a0a322025-12-03WarningsExact identifier
ndc (package): 69842-309-25
ndc (product): 69842-309
ndc11 (package): 69842030925
spl id: 4510ebed-8e70-ab7c-e063-6294a90ad4fa
spl set id: 4510f379-c5a4-92c3-e063-6294a90a0a32

Reported adverse events (FAERS/openFDA)#

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