Label: RETAIL HAND SANITIZER- alcohol liquid

  • 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 14, 2022

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  • Active ingredient

    Ethanol 60% by volume

  • Purpose

    Antispetic handwash

  • Uses

    • For handwashing to decrease bacteria on the 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
    • On deep cuts or puncture wounds

    When using this product

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

    Stop use and ask a doctor if

    • Eye or skin irritation or redenss 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 are around nails and between fingers
  • Other information

    • For additional information, see Safety Data Sheet (SDS)
    • For emergency medical information in USA, call (877) 231-2615 or call collect 0 (952) 853-1713
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions? Call 1-800-529-5458

  • Principal display panel and representative label

    NDC 63146-311-09

    RETAIL

    Hand Sanitizer

    Sanitizante de manos

    KEEP OUT OF REACH OF CHILDREN • FOR INSTITUTIONAL USE ONLY

    MANTENGASE FUERA DEL ALCANCE DE LOS NIÑOS • SOLO PARA USO INSTITUCIONAL

    Ethanol 60% by volume

    60% de etanol por volume

    Net contents: 40.6 US fl oz (1200 ml)

    FRSUSA 777648/8000/0920

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

    Cumple con los requisitos estipulados de antisépticos para manos tal como se especifican en la sección 2-301.16 del Código Modelo para Alimentos

    (2017 Model Food Code).

    SDS-NC-872, SDS-NJ-20007

    Distributed by / Distribuido por:

    Kay Chemical Company

    8300 Capital Drive · Greensboro, NC 27409-9790 USA

    Customer Service: (800) 529-5458

    ©2020 Kay Chemical Company

    All rights reserved | Todas los derechos reservados

    Made in USA | Hecho en Estados Unidos

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

    www.ecolab.com/patents

    representative label

  • INGREDIENTS AND APPEARANCE
    RETAIL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-311
    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 B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MYRISTYL ALCOHOL (UNII: V42034O9PU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-311-091200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/10/2020
    Labeler - Kay Chemical Company (003237021)
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