Label: LYFE CO HAND SANITIZER 70 PERCENT- ethanol gel

  • Category: HUMAN OTC DRUG LABEL

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 June 4, 2020

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  • ACTIVE INGREDIENT

    ETHANOL 70%

  • PURPOSE

    ANTISEPTIC

  • USES

    HAND SANITIZER TO HELP REDUCE COMMON BACTERIA AND VIRUSES THAT CAN POTENTIALLY CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

  • WARNINGS

    FOR EXTERNAL USE ONLY. FLAMMABLE.

    KEEP AWAY FROM HEAT OR FLAME.

    DO NOT USE

    • ON CHILDREN LESS THAN 2 MONTHS OF AGE.
    • ON OPEN SKIN WOUNDS.

    WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

  • 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

    • PLACE ENOUGH PRODUCT ON HANDS TO COVER ALL SURFACES. RUB HANDS TOGETHER UNTIL DRY.
    • SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.

  • OTHER INFORMATION

    • STORE BETWEEN 15-30°C (59-86°F)
    • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F)
  • INACTIVE INGREDIENTS

    ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, AMINOMETHYL PROPANOL, CARBOMER, GLYCERIN, MENTHA PIPERITA (PEPPERMINT) OIL, PROPANEDIOL, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, WATER (AQUA)

  • PRINCIPAL DISPLAY PANEL

    01b LBL_LYFE_Hand Sanitizer_473mL

  • INGREDIENTS AND APPEARANCE
    LYFE CO HAND SANITIZER  70 PERCENT
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78559-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78559-101-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2020
    2NDC:78559-101-18236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2020
    3NDC:78559-101-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2020
    4NDC:78559-101-1260 mL in 1 BOTTLE; Type 0: Not a Combination Product06/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/03/2020
    Labeler - LYFE CO WELLNESS LLC (120802485)
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