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

  • NDC Code(s): 75814-102-01, 75814-102-02, 75814-102-08
  • Packager: SERENITY TECHNOLOGIES INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 4, 2020

If you are a consumer or patient please visit this version.

  • 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)