Label: HAND SANITIZER- isopropyl alcohol, copper, silver, potassium alum, and camphor oil, white gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated May 4, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Isopropyl Alcohol ( 700 mL/L)

    Ionized Copper Nanoparticles 40-60 nm (2-4 ppm)

    Ionized Silver Nanoparticles 5 nm (1-2 ppm)

    Food grade Alum (1% vol)

    White Camphor Oil (< 1% vol)

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria and viruses on the skin

  • Warnings

    Flammable, keep away from fire and flames. For external use only

    When using this product

    • Keep out of eyes
    • If contact occurs, rinse eyes throughly with water

    Stop use and a doctor if

    • irritation and redness develop

    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, rub hands briskly and allow to dry. No rinsing or towels required.

  • Inactive Ingredients

    Water, hyaluronic acid, aloe barbadensis, glycerine

  • PRINCIPAL DISPLAY PANEL - 59.1 ml Bottle Label

    NANO TECHNOLOGY
    WITH IONIZED COPPER & SILVER

    ALLOUT™
    nano

    ADVANCED
    SKIN NOURISHING
    WITH HYALURONIC ACID

    Instant HAND
    SANITIZER
    GEL With
    Powerful Antimicrobial Action
    Gentle on Skin
    No Dyes, Colorants or Fragrances

    Kills Bacteria & Viruses

    CLEAN HANDS

    COUNT

    2 fl oz (59.1 ml)

    Principal Display Panel - 59.1 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    isopropyl alcohol, copper, silver, potassium alum, and camphor oil, white gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75814-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL750 mL  in 1000 mL
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER3 mg  in 1000 mL
    SILVER (UNII: 3M4G523W1G) (SILVER - UNII:3M4G523W1G) SILVER1.5 mg  in 1000 mL
    POTASSIUM ALUM (UNII: 1L24V9R23S) (ALUMINUM HYDROXIDE - UNII:5QB0T2IUN0) POTASSIUM ALUM100 mg  in 1000 mL
    CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X) (CAMPHOR OIL, WHITE - UNII:26P3H26Z9X) CAMPHOR OIL, WHITE9 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    hyaluronic acid (UNII: S270N0TRQY)  
    glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75814-102-0129.6 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    2NDC:75814-102-0259.1 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    3NDC:75814-102-08236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other04/27/2020
    Labeler - SERENITY TECHNOLOGIES INC. (829399240)
    Establishment
    NameAddressID/FEIBusiness Operations
    SERENITY TECHNOLOGIES INC.829399240MANUFACTURE(75814-102)
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