Label: PROBIOTIC HAND SANITIZER 75 PERCENT ALCOHOL- 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 March 5, 2021

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 75% (V/V)

  • PURPOSE

    ANTISEPTIC

  • USES

    • HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.

  • WARNINGS

    FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

    THIS PRODUCT IS INTENDED FOR EXTERNAL USE ONLY.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH APPEARS AND LASTS.

    DO NOT USE ON DAMAGED OR BROKEN SKIN.

    WHEN USING THIS PRODUCT DO NOT USE IN OR NEAR THE EYES. IN CASE OF CONTACT, RINSE THOROUGHLY WITH WATER.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    • PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HANDS TOGETHER BRISKLY UNTIL DRY (APPROXIMATELY 30 SECONDS).
    • CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.
  • OTHER INFORMATION

    • STORE BELOW 110°F (43°C)
    • MAY DISCOLOR CERTAIN FABRICS

  • INACTIVE INGREDIENTS

    TEA TREE & LEMONGRASS: WATER (AQUA), HYDROXYPROPYLCELLULOSE, CYMBOPOGON SCHOENANTHUS (LEMONGRASS) OIL, HANSENULA/KLOECKERA/LACTOBACILLUS/LACTOCOCCUS/LEUCONOSTOC/PEDIOCOCCUS/SACCHARYOMYCES/FIG/LEMON FERMENT (KEFIR PROBIOTIC), ECHINACEA ANGUSTIFOLIA EXTRACT (CONEFLOWER), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, THYMUS VULGARIS (THYME) LEAF EXTRACT, GLYCERIN, SAMBUCUS NIGRA FRUIT JUICE (ELDERBERRY), SORBITAN OLEATE, CELLULOSE GUM, CHITOSAN (PLANT), ISOEICOSANE, CITRIC ACID

    TEA TREE OIL: WATER (AQUA), HYDROXYPROPYLCELLULOSE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, HANSENULA/KLOECKERA/LACTOBACILLUS/LACTOCOCCUS/LEUCONOSTOC/PEDIOCOCCUS/SACCHARYOMYCES/FIG/LEMON FERMENT (KEFIR PROBIOTIC), THYMUS VULGARIS (THYME) LEAF EXTRACT, GLYCERIN, ECHINACEA ANGUSTIFOLIA EXTRACT (CONEFLOWER), SAMBUCUS NIGRA FRUIT JUICE (ELDERBERRY), SORBITAN OLEATE, CELLULOSE GUM, CHITOSAN (PLANT), ISOEICOSANE, CITRIC ACID

    TEA TREE & LAVENDER: WATER (AQUA), HYDROXYPROPYLCELLULOSE, LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL, HANSENULA/KLOECKERA/LACTOBACILLUS/LACTOCOCCUS/LEUCONOSTOC/PEDIOCOCCUS/SACCHARYOMYCES/FIG/LEMON FERMENT (KEFIR PROBIOTIC), SAMBUCUS NIGRA FRUIT JUICE (ELDERBERRY), MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, GLYCERIN, ECHINACEA ANGUSTIFOLIA EXTRACT (CONEFLOWER), THYMUS VULGARIS (THYME) LEAF EXTRACT, SORBITAN OLEATE, CELLULOSE GUM, CHITOSAN (PLANT), NATURAL FRAGRANCE (PARFUM), ISOEICOSANE, CITRIC ACID

    TEA TREE & PEPPERMINT: WATER (AQUA), HYDROXYPROPYLCELLULOSE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL, HANSENULA/KLOECKERA/LACTOBACILLUS/LACTOCOCCUS/LEUCONOSTOC/PEDIOCOCCUS/SACCHARYOMYCES/FIG/LEMON FERMENT (KEFIR PROBIOTIC), ILLICIUM VERUM (ANISE) FRUIT/SEED OIL, MENTHA ARVENSE LEAF OIL (MINT), EUCALYPTUS GLOBULUS LEAF OIL, THYMUS VULGARIS (THYME) LEAF EXTRACT, GLYCERIN, VANILLIN, SAMBUCUS NIGRA FRUIT JUICE (ELDERBERRY), ECHINACEA ANGUSTIFOLIA EXTRACT (CONEFLOWER), TRIETHYL CITRATE, SORBITAN OLEATE, CELLULOSE GUM, CHITOSAN (PLANT), ISOEICOSANE, CITRIC ACID

    BLOD ORANGE:  Illicium Verum (Anise) Fruit/Seed Oil, Ocimum Basilicum (Basil) Oil, Citrus Aurantium Bergamia Fruit Oil (Bergamot), Cananga Odorata Flower Oil (Ylang), Cymbopogon Nardum (Citronella) Oil, Pelargonium Graveolens Oil (Geranium), Citrus Paradisi (Grapefruit) Peel Oil, Litsea Cubeba Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Mentha Viridis (Spearmint) Leaf Oil, Citrus Reticulata (Tangerine) Peel Oil

  • PRINCIPAL DISPLAY PANEL

    01b LBL_DE_Probiotic Hand Sanitizer_Tea Tree Oil_8oz

    01b LBL_DE_Probiotic Hand Sanitizer_Tea Tree-Lavender_8oz.

    01b LBL_DE_Probiotic Hand Sanitizer_Tea Tree-Lemongrass_8oz01b LBL_DE_Probiotic Hand Sanitizer_Tea Tree-Peppermint_1.7oz

    01b LBL_DE_Probiotic Hand Sanitizer_Blood orange_8oz

  • INGREDIENTS AND APPEARANCE
    PROBIOTIC HAND SANITIZER  75 PERCENT ALCOHOL
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81001-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    KEFIRAN (UNII: 8L821V6V99)  
    THYME (UNII: CW657OBU4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    EUROPEAN ELDERBERRY JUICE (UNII: Z4IFJ0AK1E)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CYMBOPOGON SCHOENANTHUS OIL (UNII: XE7K568ILO)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ANISE OIL (UNII: 6Y89129C8H)  
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    VANILLIN (UNII: CHI530446X)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    BASIL OIL (UNII: Z129UMU8LE)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    LITSEA OIL (UNII: 2XIW34BN6O)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    TANGERINE (UNII: KH3E3096OO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81001-101-08238 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2020
    2NDC:81001-101-0250.28 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2020
    3NDC:81001-101-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product11/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/13/2020
    Labeler - Country Life Vitamins (060345436)
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