FDA.reportPublic FDA data

OWN BEAUTY - HAND SANITIZER GEL (62% ETHYL ALCOHOL), 78265-5014

Manufacturer
Own Beauty LLC
Effective date
2021-12-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:45:57

Label at a glance#

ProductOWN BEAUTY - HAND SANITIZER
Active ingredientALCOHOL
Label structure9 sections

Indications and uses

FOR HAND WASHING TO DECREASE BACTERIA ON SKIN.

Dosage and administration

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO AIR DRY.

Storage and handling

STORE AT ROOM TEMPERATURE. MAY DISCOLOR CERTAIN FABRICS.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

ETHANOL 62%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

FOR HAND WASHING TO DECREASE BACTERIA ON SKIN.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

DO NOT USE IN EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER. STOP USE AND ASK A DOCTOR IF REDNESS AND IRRITATION DEVELOP AND PERSISTS FOR MORE THAN 72 HOURS.

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

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO AIR DRY.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE. MAY DISCOLOR CERTAIN FABRICS.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

CITRUS + SAGE: PURIFIED WATER, GLYCERIN, CARBOMER, TRIETHANOLAMINE, TOCOPHERYL ACETATE, COCONUT OIL, CITRUS MEDICA (LEMON) PEEL OIL, ALOE VERA, FRAGRANCE, TRIETHYL CITRATE, CITRUS LIMON (LEMON) PEEL EXTRACT, CITRUS AURANTIFOLIA (LIME) PEEL EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) PEEL EXTRACT, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT, VANILLA PLANIFOLIA (VANILLA) FRUIT EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT

GREEN TEA + CUCUMBER: AQUA/WATER, GLYCERIN, CARBOMER, TRIETHANOLAMINE, TOCOPHERYL ACETATE, COCOS NUCIFERA (COCONUT) OIL, ALOE BARBADENSIS (ALOE) LEAF JUICE, TRIETHYL CITRATE, CITRUS MEDICA (LEMON) PEEL OIL, CAMELIA SINENSIS (GREEN TEA) LEAF EXTRACT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, SANTALUM ALBUM (SANDALWOOD) WOOD EXTRACT, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER/LEAF/STEM EXTRACT, PYRUS MALUS (APPLE) FRUIT EXTRACT, ELLETERIA CARDAMOMUM (CARDAMOM) SEED EXTRACT, RUBUS IDEAUS (RASPBERRY) FRUIT EXTRACT, ROSA CENTIFOLIA (ROSE) EXTRACT, CUCUMIS MELO (MELON) FRUIT EXTRACT, CAMELIA SINENSIS (BLACK TEAT) LEAF EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, SALVIA OFFICINALIS (SAGE) LEAF EXTRACT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7826578265

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581660ethanol 62 % Topical GelPSN8
581660ethanol 0.62 ML/ML Topical GelSCD8
581660ethanol 62 % Topical GelSY8

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78265-5014-12023-01-30C16284748780-1f386c64a-1bd0-0266-e053-dadaa90a7c1aOWN BEAUTY - HAND SANITIZER GEL (62% ETHYL ALCOHOL), 78265-5014
78265-5014-22023-01-30C16284748780-1f386c64a-1bd0-0266-e053-dadaa90a7c1aOWN BEAUTY - HAND SANITIZER GEL (62% ETHYL ALCOHOL), 78265-5014
78265-5014-52023-01-30C16284748780-1f386c64a-1bd0-0266-e053-dadaa90a7c1aOWN BEAUTY - HAND SANITIZER GEL (62% ETHYL ALCOHOL), 78265-5014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78265-5014-1OWN BEAUTY - HAND SANITIZER236 mL in 1 BOTTLEGEL2368
78265-5014-2OWN BEAUTY - HAND SANITIZER59 mL in 1 BOTTLEGEL598
78265-5014-5OWN BEAUTY - HAND SANITIZER200 mL in 1 BOTTLEGEL2008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78265-5014OWN BEAUTY - HAND SANITIZER (ETHYL ALCOHOL) GEL [OWN BEAUTY LLC]8Legacy NDC, 3 package rows20211228_943e4910-be34-4c12-9d15-e4e0355483d4.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78265-501478265-5014-5, 78265-5014-2, 78265-5014-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
SANDALWOOD3641YW25N2IACT
BERGAMOT ORANGEIET5D90X0DIACT
CUCUMIS MELO WHOLERDC232W0M5IACT
ROSEMARYIJ67X351P9IACT
ROSA CENTIFOLIA FLOWERCS4TE8FF7OIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCONUT OILQ9L0O73W7LIACT
LEMON OILI9GRO824LLIACT
ALOE VERA LEAFZY81Z83H0XIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
LEMON PEEL72O054U628IACT
ORANGE PEELTI9T76XD44IACT
SAGE065C5D077JIACT
VANILLAQ74T35078HIACT
CUCUMBERYY7C30VXJTIACT
ALCOHOL3K9958V90MACTIB
APPLE JUICE9871T0PD5PIACT
CARDAMOM8BC4CUT4JLIACT
RASPBERRY4N14V5R27WIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
LAVANDULA ANGUSTIFOLIA WHOLE51217XIL5LIACT

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
d4279951-fb37-22a3-e053-2995a90a9992943e4910-be34-4c12-9d15-e4e0355483d42021-12-27WarningsExact identifier
spl id: d4279951-fb37-22a3-e053-2995a90a9992
spl set id: 943e4910-be34-4c12-9d15-e4e0355483d4

Reported adverse events (FAERS/openFDA)#

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