FDA.reportPublic FDA data

ALOE VERA CENTER HAND SANITIZER

Manufacturer
SOMBRA COSMETICS
Effective date
2020-07-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:21

Label at a glance#

ProductALOE VERA CENTER HAND SANITIZER
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Helps reduce bacteria on the skin that could cause diseases.

Dosage and administration

Place enough product in the palm of your hands to thoroughly cover your hands. Rub hands together briskly until product is completely absorbed and hands are dry.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (105F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65%

Uses

INDICATIONS & USAGE SECTION

Helps reduce bacteria on the skin that could cause diseases.

Warnings

WARNINGS SECTION

Flammable. Keep away from fire or flame. For external use only.

Do not use

OTC - DO NOT USE SECTION

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

When Using

OTC - WHEN USING SECTION

When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Place enough product in the palm of your hands to thoroughly cover your hands. Rub hands together briskly until product is completely absorbed and hands are dry.

Other information

STORAGE AND HANDLING SECTION

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (105F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, aloe barbadensis leaf extract, camellia sinensis (green tea) leaf extract, purified water, isopropyl alcohol, polyacrylate crosspolymer-6, rosa damascena flower water, hamamelis virginiana (witch hazel) leaf extract, citrus aurantium dulcis (orange) peel oil, filipendula ulmaria (queen of the prairie) extract, yucca schidigera root extract

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aloe Vera 8oz gelAloe Vera 8oz gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
902574ethanol 65 % Topical GelPSN2
902574ethanol 0.65 ML/ML Topical GelSCD2
902574ethyl alcohol 65 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-1113-22024-01-30C16284748780-11030e364-fe1c-111a-e063-dadaa90a10e2Aloe Vera Center Hand Sanitizer
61577-1113-42024-01-30C16284748780-11030e364-fe1c-111a-e063-dadaa90a10e2Aloe Vera Center Hand Sanitizer
61577-1113-82024-01-30C16284748780-11030e364-fe1c-111a-e063-dadaa90a10e2Aloe Vera Center Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-1113-2ALOE VERA CENTER HAND SANITIZER54 mL in 1 BOTTLE, PLASTICGEL542
61577-1113-4ALOE VERA CENTER HAND SANITIZER118 mL in 1 BOTTLE, PLASTICGEL1182
61577-1113-8ALOE VERA CENTER HAND SANITIZER236 mL in 1 BOTTLE, PLASTICGEL2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-1113ALOE VERA CENTER HAND SANITIZER (ALCOHOL) GEL [SOMBRA COSMETICS]2Legacy NDC, 3 package rows20200724_769d67c5-3936-40e9-a5be-c3de7ea5a336.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61577-111361577-1113-8, 61577-1113-4, 61577-1113-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
ROSA DAMASCENA FLOWERJWB78P295AIACT
WITCH HAZEL101I4J0U34IACT
ORANGE OILAKN3KSD11BIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
FILIPENDULA ULMARIA WHOLE3LH0M209LNIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
YUCCA SCHIDIGERA STEMN59C6T6D72IACT
ALCOHOL3K9958V90MACTIB

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
ab223010-c726-7b75-e053-2a95a90acf14769d67c5-3936-40e9-a5be-c3de7ea5a3362020-07-23WarningsExact identifier
spl id: ab223010-c726-7b75-e053-2a95a90acf14
spl set id: 769d67c5-3936-40e9-a5be-c3de7ea5a336

Reported adverse events (FAERS/openFDA)#

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