Label: CENTER FOR APPLIED INNOVATION LLC HAND SANITIZER- 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 August 20, 2020

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

  • Drug Facts

  • Active ingredient[s]

    Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Uses[s]

    Hand sanitizer to help reduce bacteria that potentially can 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

    • in 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. 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 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive Ingredients

    glycerin, hydrogen peroxide, purified water USP

  • SPL UNCLASSIFIED SECTION

    Make all things clear

    Alcohol Antiseptic 80%

    Topical Solution

    Antiseptic Hand Rub

    Non-Sterile Solution

    MADE IN U.S.A

    100% Recyclable PET bottle

    Do Not Drink!

    Help us help our Heroes and those in need.

    Help us continue to provide support to those in need by a tax deductible contribution

    Text HEROES2 to 71777 to learn how!

    Manufactured, Packaged and Distributed By:

    Glenway Farms Inc

    1437 Hume Rd.

    Huntly, VA 22640

    Questions? Comments?

    covid19@vahandsanitizer.com

    www.vahandsanitizer.com

    FLAMMABLE FOR EXTERNAL USE ONLY

    Formulated to meet/exceed all WHO, CDC, and USP requirements

    MADE IN VIRGINIA

    "By Virginia Small Businesses

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    CENTER FOR APPLIED INNOVATION LLC HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74372-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74372-002-01500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/20/2020
    Labeler - GLENWAY FARMS, INC. (106160334)
    Establishment
    NameAddressID/FEIBusiness Operations
    GLENWAY FARMS, INC.106160334manufacture(74372-002)