Label: MELI HANDS HAND SANITIZER- ethyl alcohol spray

  • 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 September 14, 2022

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  • Drug Facts

  • Active Ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Use

    To help reduce bacteria on the skin.

  • Warnings

    For external use only. Flammable. Keep away from flame or high heat.

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or redness develop.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Spray or pump a small amount into the palm of your dry hands, rub and wait until evaporated. Children under 6 should be supervised when using this product.

  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice, Amyris Oil, Caryophellen Beta, Cedarwood TX, CIS-3-Hexenyl Acetate Natural, Fir Balsam, Fir Needle Oil Siberian, Glycerin, Grapefruit Oil (Pink), Hexyl Acetate Natural, Isopropyl Myristate, Orange Oil CP, PEG-6(and) AMP-Acrylates/Vinyl Isodecanoate Crosspolymer, Raspberry Ketone Natural, Rosemary Oil Spanish, Terpineol Alpha Natural, Triethyl Citrate Natural(TEC), Tocopheryl Acetate, Water

  • Questions or Comments

    info@melihands.com

  • SPL UNCLASSIFIED SECTION

    ALOE VERA + ESSENTIAL OILS

    CHRISTMAS TREE

    Meli Hands, LLC Dallas, TX 75248 www.melihands.com

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    MELI HANDS HAND SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79426-104
    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)  
    AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
    CARYOPHYLLENE (UNII: BHW853AU9H)  
    JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)  
    3-HEXENYL ACETATE, (3Z)- (UNII: 6INA6GC5I6)  
    CANADA BALSAM (UNII: K304VI98I3)  
    ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    HEXYL ACETATE (UNII: 7U7KU3MWT0)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) (UNII: 2N8MDB79NA)  
    4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    TERPINEOL (UNII: R53Q4ZWC99)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79426-104-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/13/2020
    2NDC:79426-104-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/13/2020
    3NDC:79426-104-08237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/13/2020
    4NDC:79426-104-16473 mL in 1 BOTTLE, SPRAY; 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 - MELI HANDS, LLC (117561450)
    Establishment
    NameAddressID/FEIBusiness Operations
    PreMark Health Science, Inc004039083manufacture(79426-104)
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