Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 51706-902-01, 51706-902-02, 51706-902-03, 51706-902-04
  • Packager: Landy International
  • 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 March 21, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient(s)

    Ethyl Alcohol 62%

  • Purpose

    Antiseptic

  • Use

    ■decreases bacteria on the skin that could cause disease
    ■recommended for repeated use

  • Warnings

    For external use only: hands
    Flammable, keep away from fire 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 doctor if
    ■irritation and redness develop
    n condition persists for more than 72 hours

  • 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

    ■wet hands thoroughly with product and allow to dry without wiping
    for children under 6, use only under adult supervision
    not recommended for infants

  • Inactive ingredients

    Inactive Ingredient Water(Aqua), Acrylates/C10 30 alkyl arylate crosspolymer,
    Glycerin, Triethanolamine, Fragrance (Parfum), Tocopheryl Acetate, Aloe barbadensis-
    leaf extract, Denatonium Benzoate, Phenoxyethanol, Ethylhexylglycerin.

  • Package Label - Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51706-902
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51706-902-01975 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    2NDC:51706-902-02500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    3NDC:51706-902-0389 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    4NDC:51706-902-04236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2020
    Labeler - Landy International (545291775)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51706-902)
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, PubMed, Biochemical Data Summary

More Info on this Drug

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