FDA.reportPublic FDA data

Signature Care Aloe Vera Gel with Lidocaine

Manufacturer
Safeway, Inc.
Effective date
2025-08-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:10:44

Label at a glance#

ProductSignature Care Aloe Vera Gel with Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
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

aleurites moluccanus seed extract, allantoin, aloe barbadensis leaf juice, benzyl alcohol, blue 1, carbomer, carica papaya (papaya) fruit extract, colocasia antiquorum root extract, disodium EDTA, fragrance, glycerin, laureth-23, mangifera indica (mango) fruit extract, menthol, menthyl lactate, passiflora incarnata flower extract, phenoxyethanol, plumeria acutifolia flower extract, polysorbate 20, propylene glycol, psidium guajava fruit extract, SD alcohol 40-B, tocopherol, tocopheryl acetate (vitamin e), triethanolamine, water.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SY74630E6SY74630E6

SY74630F6SY74630F6

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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-733-68Signature Care Aloe Vera Gel with Lidocaine454 g in 1 BOTTLEGEL4543

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-73321130-733-68

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
FD&C BLUE NO. 1H3R47K3TBDIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
PLUMERIA ALBA FLOWER OILT69Z2432CUIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZYL ALCOHOLLKG8494WBHIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
ndc (package): 21130-733-68
ndc (product): 21130-733
ndc11 (package): 21130073368
spl id: 3c5b0074-309a-fdba-e063-6394a90a2502
spl set id: d5069622-97b1-ba12-e053-2a95a90a7268

Reported adverse events (FAERS/openFDA)#

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