Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 June 23, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 62%

  • Purpose

     Antiseptic

  • Use

    hand sanitizing to reduce bacteria on skin.

  • Warnings

    For external use only

    Flammable. Keep away from fire and flame.

    When using this product

    do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

    Keep out of reach of children.

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

  • Directions

    Place product on hands, rub until dry.

  • Inactive ingredients

    Glycerin, Propylene Glycol, Triethanolamine, Carbomer, Fragrance, Disodium edtatocopheryl acetate, Deionized Water

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75613-005
    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:75613-005-018 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/23/202006/24/2020
    2NDC:75613-005-0210 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/23/202006/24/2020
    3NDC:75613-005-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/23/2020
    Labeler - Ningbo Lanzi Cosmetic Technology Co., Ltd (554530929)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Lanzi Cosmetic Technology Co., Ltd554530929manufacture(75613-005)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!