Label: PROBIOTIC HAND SANITIZING WIPES- alcohol solution

  • 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 January 2, 2021

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  • ACTIVE INGREDIENT

    ALCOHOL 65% (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 SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • APPLY WIPES DIRECTLY TO HANDS AND ALLOW TO AIR DRY. DO NOT APPLY TO FACE OR EYES.

  • OTHER INFORMATION

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

  • INACTIVE INGREDIENTS

    TEA TREE & LEMONGRASS: WATER (AQUA), 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), 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), 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

  • QUESTIONS?

    CALL 800-645-5768

  • PRINCIPAL DISPLAY PANEL

    01b LBL_DE_Probiotic Hand Sanitizer Wipes_Tea Tree-Lemongrass_20ct

    01b LBL_DE_Probiotic Hand Sanitizer Wipes_Tea Tree Oil_20ct

    01b LBL_DE_Probiotic Hand Sanitizer Wipes_Tea Tree-Lavender_20ct

  • INGREDIENTS AND APPEARANCE
    PROBIOTIC HAND SANITIZING WIPES 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81001-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL6.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    KEFIRAN (UNII: 8L821V6V99)  
    THYME (UNII: CW657OBU4N)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81001-102-2010 in 1 BOX01/02/2021
    1NDC:81001-102-011 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/02/2021
    Labeler - Country Life Vitamins (060345436)
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