Label: HAND SANITIZER- 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 November 11, 2021

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 62%

  • Purpose

     Antiseptic

  • Use

    For hand sanitizing

  • Warnings

    For external use only.

    Flammable. Keep product away from heat or flame.

    When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

    Do not inhale or ingest.

    Stop use and ask a doctor if skin irritation develops.

    Keep out of reach of children.

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

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • For children under 6 age use only under adult supervision.
    • Not recommended for infants.
  • Inactive ingredients

    Carbomer, Fragrance, Glycerol, Propylene Glycol, Triethanolamine, Disodium Edta, Tocopheryl Acetate, Deionized Water

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75613-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75613-020-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/11/2021
    Labeler - Ningbo Lanzi Cosmetic Technology Co., Ltd (554530929)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Lanzi Cosmetic Technology Co., Ltd554530929manufacture(75613-020)
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