Label: EVERY FRESH HAND SANITIZER- ethyl alcohol gel

  • 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 January 21, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Ethyl Alcohol, 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • To help reduce bacteria on the skin
    • For use when soap and water are not available
  • Warnings

    For external use only. Flammable, keep away from fire or flame.

    When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

    Stop use and ask a doctor if significant irritation or sensitization develops.

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

  • Directions

    -Put enough product on your palm to cover hands and rub your hands together until dry.

    -Children under 6years should be supervised when using this product.

  • Other Information

    Store below 43°C (110°F)

    May discolor certain fabrics

  • Inactive Ingredients

    carbomer, aminomethyl propanol, glycerin, water, tocopheryl acetate (Vit E).

  • PRINCIPAL DISPLAY PANEL

    711

    2

    5

  • INGREDIENTS AND APPEARANCE
    EVERY FRESH HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-015
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76772-015-05148 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    2NDC:76772-015-23236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    3NDC:76772-015-71710 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    4NDC:76772-015-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/21/2020
    Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
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