Label: HAND SANITIZER- alcohol aerosol, 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 April 15, 2020

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  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

    Antiseptic

  • Flammable

    Keep away from heat or flame

  • Keep out of reach of children.

    If ingested get medical help or call a Poison Control Center immediately.

  • Directions and Use

    For use when soap and water aren’t available. Spray product on hands to cover all surfaces. Rub hands together until dry. Not for children under 2mo. Do not use on open wounds. Stop use if irritation or rash occur. For external use only.

  • 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.
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Other information

    Store below 40C (104F). Avoid freezing.

  • Package Label - Principal Display Panel

    Drug Facts

    Product Label

    118 mL NDC: 75554-417-20

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75554-417
    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) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75554-417-20118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/15/2020
    Labeler - The Lavender Shop (047876293)
    Registrant - The Lavender Shop (047876293)
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