FDA.reportPublic FDA data

Sunburn Pain relief

Manufacturer
Top Care | Product Quest Mfg
Effective date
2018-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:04

Label at a glance#

ProductSunburn Pain relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure6 sections

Indications and uses

sunburn minor burns insect bites cuts scrapes

Dosage and administration

• adults and children 2 years of age and older: apply to affected area, not more than 3 to 4 times a day • children under 2 years of age: consult a physician

Label contents#

Full prescribing information#

Active ingredient                                             Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 0.5%                        External analgesic

Uses for temporary relief of pain and itching due to

INDICATIONS & USAGE SECTION

  • sunburn
  • minor burns
  • insect bites
  • cuts
  • scrapes

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. Rinse with water if contact occurs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• symptoms last more than 7 days.

Keep out of reach of the children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 2 years of age and older: apply to affected area, not more than 3 to 4 times a day
• children under 2 years of age: consult a physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Blue 1, Carbomer, Diazolidinyl Urea, Disodium EDTA, Glycerin, Isopropyl Alcohol, Menthol, Polysorbate 80,
Propylene Glycol, Triethanolamine, Water, Yellow 5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011849lidocaine HCl 0.5 % Topical GelPSN1
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCD1
1011849lidocaine hydrochloride 0.5 % Topical GelSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130036800663671GTIN-13: 0036800663671
EAN-13: 0036800663671
GTIN-12: 036800663671
UPC-A: 036800663671
GTIN storage (14 digits): 00036800663671		label.jpg

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
36800-883-062020-01-31C16284748780-19d75b9d0-7e85-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-883-06Sunburn Pain relief1 in 1 CARTONGEL11
36800-883-06Sunburn Pain relief237 mL in 1 BOTTLEGEL2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-883SUNBURN PAIN RELIEF (LIDOCAINE HYDROCHLORIDE 0.5%) GEL [TOP CARE]1Legacy NDC, 2 package rows20180626_caf83b63-604e-43ae-85a0-b31db5fd2388.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-88336800-883-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
Diazolidinyl UreaH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
GlycerinPDC6A3C0OXIACT
Isopropyl AlcoholND2M416302IACT
MentholL7T10EIP3AIACT
Polysorbate 806OZP39ZG8HIACT
Propylene Glycol6DC9Q167V3IACT
TROLAMINE9O3K93S3TKIACT
Water059QF0KO0RIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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
3b45baff-4756-4895-b9df-486b605665a0caf83b63-604e-43ae-85a0-b31db5fd23882018-06-26WarningsExact identifier
spl id: 3b45baff-4756-4895-b9df-486b605665a0
spl set id: caf83b63-604e-43ae-85a0-b31db5fd2388

Reported adverse events (FAERS/openFDA)#

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