Label: 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 January 21, 2022

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  • SPL UNCLASSIFIED SECTION

    The hand sanitizer is manufactured using only the following ingredients:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerol (1.45% v/v).
    3. Hydrogen peroxide (0.125% v/v).
    4. Sterile distilled water or boiled cold water.
    5. Fragrance
  • Active Ingredient(s)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

  • 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

    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.

  • STOP USE

    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.

  • 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, fragrance

  • Package Label - Principal Display Panel

    55 gallons NDC: 75009-680-01

    208190 ml label

    275 gallons NDC:75009-680-02

    1040980 ml label

    5 gallons NDC:75009-680-03

    18920 ml label

    1 gallon NDC:75009-680-04

    3780 ml label

    1 quart NDC: 75009-680-05

    946 ml label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75009-680
    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
    DIHYDROMYRCENOL (UNII: 46L1B02ND9) 0.02 mL  in 100 mL
    4-TERT-BUTYLCYCLOHEXYL ACETATE (UNII: 21EUM2B8UC) 0.01 mL  in 100 mL
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) 0.005 mL  in 100 mL
    LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.05 mL  in 100 mL
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.02 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662) 0.03 mL  in 100 mL
    PIPERONAL (UNII: KE109YAK00) 0.005 mL  in 100 mL
    LINALYL ACETATE (UNII: 5K47SSQ51G) 0.07 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75009-680-01208190 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    2NDC:75009-680-021040980 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/30/2020
    3NDC:75009-680-0318920 mL in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    4NDC:75009-680-043780 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
    5NDC:75009-680-05946 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Alpha Aromatics (041723545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alpha Aromatics041723545manufacture(75009-680)
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