Label: KAY ACTIGEL- ethanol solution

  • 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 July 14, 2023

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  • Active ingredient

    Ethanol 60% by volume

  • Purpose

    Antiseptic handwash

  • Uses

    • For handwashing to decrease bacteria on the skin
  • Warnings

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

    Do not use

    • In eyes
    • On deep cuts or puncture wounds

    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 and redness persist 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 Material Safety Data Sheet (MSDS)
    • For emergency medical information in the USA call 1 (877) 231-2615 or call collect 0 (952)853-1713
  • Inactive ingredients

    water (aqua), isopropyl alcohol, triethanolamine, acrylates/C10-C30 alkyl acrylate crosspolymer, propylene glycol, myristyl alcohol

  • QUESTIONS

    ​Questions? call 1-800-529-5458

  • Principal Display Panel/Representative Label

    NDC NO.: 63146-301-02

    Kay

    Actigel

    Hand Sanitizer

    To obtain instruction in Spanish, see outer carton.

    ECOLAB

    KAY CHEMICAL COMPANY

    8300 Capital Drive

    Greensboro, NC 27409-9790, USA

    Customer Service: (800) 529-5458

    SDS-NC-872

    27 US fl oz (800 ml)

    722473-03

    FRSUSA 722473/8003/0910

    ©2010 Kay Chemical Company

    All Rights Reserved

    representative label

  • INGREDIENTS AND APPEARANCE
    KAY ACTIGEL 
    ethanol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-301
    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)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-301-02800 mL in 1 BAG; Type 0: Not a Combination Product05/26/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/26/2010
    Labeler - Kay Chemical Company (003237021)
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