Label: KLENLII HAND SANII ALCOHOL SANITIZER- ethyl alcohol spray

  • NDC Code(s): 78016-101-11, 78016-101-12, 78016-101-14, 78016-101-16, view more
    78016-101-18
  • Packager: Klenlii Company
  • 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 June 14, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 63%

    ISOPROPYL ALCOHOL 7%

  • PURPOSE

    ANTISEPTIC

  • USES

    • DECREASE BACTERIA ON SKIN
  • WARNINGS

    FOR EXTERNAL USE ONLY: HANDS

    FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

    WHEN USING THIS PRODUCT

    • KEEP OUT OF EYES

    STOP USE AND ASK DOCTOR IF

    • IRRITATION OR REDNESS DEVELOPS
  • 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

    • THOROUGHLY WET HANDS WITH PRODUCT AND ALLOW TO DRY

  • INACTIVE INGREDIENTS

    DEIONIZED WATER, GLYCERIN

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Klenlii_Hand Sanii Spray_2oz

  • INGREDIENTS AND APPEARANCE
    KLENLII HAND SANII ALCOHOL SANITIZER 
    ethyl alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78016-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78016-101-18238 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    2NDC:78016-101-14118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package05/27/2020
    3NDC:78016-101-16476 mL in 1 BOTTLE; Type 0: Not a Combination Product05/27/2020
    4NDC:78016-101-113785 mL in 1 JUG; Type 0: Not a Combination Product05/27/2020
    5NDC:78016-101-1259 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 - Klenlii Company (117278596)
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!