OWN BEAUTY - HAND SANITIZER- ethyl alcohol gel 
Own Beauty LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

ACTIVE INGREDIENT

ETHANOL 62%

PURPOSE

ANTISEPTIC

USES

FOR HAND WASHING TO DECREASE BACTERIA ON SKIN.

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO AIR DRY.

OTHER INFORMATION

STORE AT ROOM TEMPERATURE. MAY DISCOLOR CERTAIN FABRICS.

INACTIVE INGREDIENTS

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

78265

OWN BEAUTY - HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78265-5014
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SANDALWOOD (UNII: 3641YW25N2)  
BERGAMOT ORANGE (UNII: IET5D90X0D)  
CUCUMIS MELO WHOLE (UNII: RDC232W0M5)  
ROSEMARY (UNII: IJ67X351P9)  
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
COCONUT OIL (UNII: Q9L0O73W7L)  
LEMON OIL (UNII: I9GRO824LL)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
LEMON PEEL (UNII: 72O054U628)  
ORANGE PEEL (UNII: TI9T76XD44)  
SAGE (UNII: 065C5D077J)  
VANILLA (UNII: Q74T35078H)  
CUCUMBER (UNII: YY7C30VXJT)  
APPLE JUICE (UNII: 9871T0PD5P)  
CARDAMOM (UNII: 8BC4CUT4JL)  
RASPBERRY (UNII: 4N14V5R27W)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78265-5014-5200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
2NDC:78265-5014-259 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
3NDC:78265-5014-1236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/04/2020
Labeler - Own Beauty LLC (052489743)

Revised: 12/2021
Document Id: d4279951-fb37-22a3-e053-2995a90a9992
Set id: 943e4910-be34-4c12-9d15-e4e0355483d4
Version: 8
Effective Time: 20211227
 
Own Beauty LLC