Label: KAY ALPHASAN HAND SANITIZER- alcohol solution

  • NDC Code(s): 63146-303-02, 63146-303-09
  • Packager: Kay Chemical Co
  • 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, 2022

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

View All Sections
  • Active ingredient

    Ethanol 60% by volume

  • Purpose

    Antiseptic Handwash

  • Uses

    • For handwashing to decrease bacteria on skin
  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame, heat, sparks and sources of static discharge.

    Do not use

    • In eyes

    When using this product

    • If in eyes, rinse promptly and thoroughly with water
    • Discontinue use if irritation and redness develop

    Stop use and ask a doctor if

    • Eye or skin irritation or redness occurs for more than 72 hours

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberal amount into hand
    • Spread by rubbing hands together
    • Rub to dryness with attention to area around nails and between fingers
  • Other information

    • THIS PRODUCT IS NOT A SUBSTITUTE FOR HANDWASHING WITH SOAP AND WATER
    • for additional information, see Safety Data Sheet (SDS)
    • for emergency medical information in USA, call 1-800-391-1504
  • Inactive Ingredients

    water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol

  • QUESTIONS

    Questions?  call 1-800-532-7732

  • Principal display panel and representative label

    ALPHASAN

    Hand Sanitizer

    Active Ingredient: Ethanol 60% by volume

    1111141

    Net Contents

    1200 mL (40.6 US FL OZ)

    Meets the requirements for Hand Antiseptics as specified in section 2-301.16 of the 2017 Model Food Code.

    SDS-NC-872, SDS-NJ-20007

    This product may be patented | Este producto puede ser patentado:

    www.ecolab.com/patents

    Distributed by:

    SSDC Division, Kay Chemical Company

    4050 Corporate Drive #100

    Grapevine, TX 76051, USA 800.532.7732

    ©2020 Kay Chemical Company.  All Rights Reserved Made in United States | Hecho en Estados Unidos

    777178/7301/0820

    representative label

  • INGREDIENTS AND APPEARANCE
    KAY  ALPHASAN HAND SANITIZER
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-303-02800 mL in 1 POUCH; Type 0: Not a Combination Product10/13/2005
    2NDC:63146-303-091200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/13/2005
    Labeler - Kay Chemical Co (003237021)
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!