Label: HAND SANITIZER- alcohol spray

  • 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 7, 2020

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  • ACTIVE INGREDIENT

    ALCOHOL (80% v/v)

  • PURPOSE

    ANTISEPTIC

  • USES

    • HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.
  • WARNINGS

    FOR EXTERNAL USE ONLY. FLAMMABLE.

    KEEP AWAY FROM FIRE OR FLAME.

    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or redness develop

  • KEEP OUT OF REACH OF CHILDREN

    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 and rub lightly until dry. Do not wipe off or rinse.

  • OTHER INFORMATION

    • May discolor fabrics or surfaces.
    • Store below 105'F (40'C)

  • INACTIVE INGREDIENTS

    Denatonium Benzoate, Glycerin, Purified Water USP

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Sinno LBY Sanitizer Spray 500ml Pump Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50069-101(NDC:75497-101)
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50069-101-11500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    2NDC:50069-101-1350 mL in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/23/2020
    Labeler - UNILEVER ASIA PRIVATE LIMITED (894632699)
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