FDA.reportPublic FDA data

Walgreens Sunburn Relief Gel

Manufacturer
WALGREEN COMPANY
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:25:24

Label at a glance#

ProductWalgreens Sunburn Relief
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations

Dosage and administration

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily • Children under 2 years of age: Ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.8% (as Lidocaine HCI)

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• condition worsens • symptoms persist for more than 7 days • symptoms clear up and occur again within a few days

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

• Children under 2 years of age: Ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, aloe barbadensis leaf juice, alcohol denat., propylene glycol, laureth-23, glycerin, polysorbate 20, allantoin, carbomer, triethanolamine, menthyl lactate, disodium EDTA, menthol, aleurites moluccanus seed extract, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, mangifera indica (mango) fruit extract, passiflora incarnata flower extract, plumeria acutifolia flower extract, psidium guajava fruit extract, tocopheryl acetate, tocopherol, phenoxyethanol, benzyl alcohol, fragrance, blue 1.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

W97751EF1W97751EF1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098616lidocaine 0.8 % Topical GelPSN3
1098616lidocaine 0.008 MG/MG Topical GelSCD3
1098616lidocaine 0.8 % Topical GelSY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0985-68Walgreens Sunburn Relief453 g in 1 BOTTLEGEL4533

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0985WALGREENS SUNBURN RELIEF (LIDOCAINE) GEL [WALGREEN COMPANY]3Current NDC, Legacy NDC, 1 package rows20241016_d5067903-c559-dc6d-e053-2995a90a8ee3.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-09850363-0985-68

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
MANGOI629I3NR86IACT
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LAURETH-23N72LMW566GIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
ALLANTOIN344S277G0ZIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
EDETATE DISODIUM7FLD91C86KIACT
LEVOMENTHOLBZ1R15MTK7IACT
KUKUI NUT OILTP11QR7B8RIACT
PAPAYAKU94FIY6JBIACT
COLOCASIA ESCULENTA ROOTH7B71Q0G0DIACT
PASSIFLORA INCARNATA FLOWERK8F3G29S6ZIACT
GUAVA74O70D6VG0IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZYL ALCOHOLLKG8494WBHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
PLUMERIA ALBA FLOWER OILT69Z2432CUIACT
LIDOCAINE98PI200987ACTIB

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 Sunburn ReliefLIDOCAINEWALGREEN COMPANYd5067903-c559-dc6d-e053-2995a90a8ee32024-10-14WarningsExact identifier
ndc (package): 0363-0985-68
ndc (product): 0363-0985
ndc11 (package): 00363098568
spl id: 247454aa-fa4d-51ef-e063-6394a90ab958
spl set id: d5067903-c559-dc6d-e053-2995a90a8ee3

Reported adverse events (FAERS/openFDA)#

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