Label: CLEAN WASH HAND SANITIZER- alcohol liquid

  • 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 April 13, 2021

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  • Active Ingredients

    Alcohol 80% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Uses Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS

    Warning For external use only. Flammable. Keep away from heat or flame.

  • DO NOT USE

    Do not use

    • on children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    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

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    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.
  • STORAGE AND HANDLING

    Other Information

    • Store between 15-30°C (59-86°F)
    • Avoid freezing and excessive heat above 40°C (104°F) 
  • INACTIVE INGREDIENT

    Inactive Ingredients Purified water, Glycerin

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    CLEAN WASH HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78174-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80.0113 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.0662 L  in 100 L
    water (UNII: 059QF0KO0R) 19.9226 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78174-051-060.118294 L in 1 BOTTLE; Type 0: Not a Combination Product04/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/13/2021
    Labeler - Custom Chemical Services, LLC (078305908)
    Registrant - Ideoto, Inc (008752031)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Chemical Services, LLC078305908manufacture(78174-051)
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