Label: OWN BEAUTY - HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 27, 2021

If you are a consumer or patient please visit this version.

  • 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

    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

  • PRINCIPAL DISPLAY PANEL

    78265

  • INGREDIENTS AND APPEARANCE
    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)