FDA.reportPublic FDA data

Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL

Manufacturer
Fruit of the Earth, Inc.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:27:14

Label at a glance#

ProductFruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL
Active ingredientLIDOCAINE
Label structure12 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.

Storage and handling

May stain some fabrics.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.8% (as Lidocaine HCl)

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 - ASK DOCTOR 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.

Other information:

STORAGE AND HANDLING SECTION

May stain some fabrics.

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 moluccarnus 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, Yellow 5.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83645EF183645EF1

83648EF183648EF1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1098616lidocaine 0.8 % Topical GelPSN2
1098616lidocaine 0.008 MG/MG Topical GelSCD2
1098616lidocaine 0.8 % Topical GelSY2

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62217-070-68Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL453 g in 1 BOTTLEGEL4532
62217-070-80Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCL227 g in 1 BOTTLEGEL2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62217-070FRUIT OF THE EARTH SUN TOWN CITY ALOE VERA AFTER SUN WITH LIDOCAINE HCL (LIDOCAINE) GEL [FRUIT OF THE EARTH, INC.]2Current NDC, Legacy NDC, 2 package rows20241019_c7a833bd-7457-73a3-e053-2a95a90ac53f.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
62217-07062217-070-80, 62217-070-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LAURETH-23N72LMW566GIACT
POLYSORBATE 207T1F30V5YHIACT
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE DISODIUM7FLD91C86KIACT
MENTHOLL7T10EIP3AIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
PLUMERIA RUBRA FLOWER8P7XXY759HIACT
MANGOI629I3NR86IACT
GUAVA74O70D6VG0IACT
PAPAYAKU94FIY6JBIACT
PASSIFLORA INCARNATA FLOWERK8F3G29S6ZIACT
COLOCASIA ESCULENTA ROOTH7B71Q0G0DIACT
ALEURITES MOLUCCANA SEEDJ87WJ3E7VWIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
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
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCLLIDOCAINEFruit of the Earth, Inc.c7a833bd-7457-73a3-e053-2a95a90ac53f2024-10-17WarningsExact identifier
ndc (package): 62217-070-80
ndc (package): 62217-070-68
ndc (product): 62217-070
ndc11 (package): 62217007080
ndc11 (package): 62217007068
spl id: 24b3c937-0f69-ef64-e063-6394a90a8e04
spl set id: c7a833bd-7457-73a3-e053-2a95a90ac53f

Reported adverse events (FAERS/openFDA)#

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