FDA.reportPublic FDA data

LUCKY sunburn relief gel

Manufacturer
Delta Brands Inc
Effective date
2023-09-07
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:26:19

Label at a glance#

ProductLUCKY SUPERSOFT sunburn relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves pain and itching associated with ■ sunburn ■ minor burns ■ minor cuts ■ scrapes ■ minor skin irritations ■ insect bites

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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching associated with

■ sunburn ■ minor burns ■ minor cuts ■ scrapes ■ minor skin irritations ■ insect bites

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

condition worsens

or if symptoms persist for more than 7 days

or symptoms clear up and occur again in a few days

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 right away.

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, glycerin, aloe barbadensis leaf juice, propylene glycol, menthol, disodium EDTA,isopropyl alcohol (0.06% v/v), polysorbate 20, carbomer, sodium hydroxide, benzyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, FD&C yellow no. 5, FD&C blue no. 1

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
20276-11020276-110-06, 20276-110-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
SODIUM HYDROXIDE55X04QC32IIACT
ISOPROPYL ALCOHOLND2M416302IACT
POLYSORBATE 207T1F30V5YHIACT
BENZYL ALCOHOLLKG8494WBHIACT
MENTHOLL7T10EIP3AIACT
EDETATE DISODIUM7FLD91C86KIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT

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
04caefa3-c505-d6c6-e063-6294a90ad8379987d72a-464b-245e-e053-2a95a90a07332023-09-07WarningsExact identifier
spl id: 04caefa3-c505-d6c6-e063-6294a90ad837
spl set id: 9987d72a-464b-245e-e053-2a95a90a0733

Reported adverse events (FAERS/openFDA)#

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