Label: CHEMSTAR 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

    Antiseptic 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 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 HANDWASHINGWITH SOAP AND WATER
    • For additional information, see Safety Data Sheet (SDS)
    • For emergency health 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

    CHEMSTAR

    RETAIL

    Hand Sanitizer

    Sanitizante de

    manos para

    Supermecados

    Ethanol 60% by volume

    60% de etanol por volume

    1111303

    Net Contents: 40.6 US fl oz (1200 ml)

    Meets the requirements for Hand Antiseptics as

    specified in section 2-301.16 of the 2017 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 Food Code).

    SDS-NC-872, SDS-NJ-20007

    CHEMSTAR

    Distributed by:

    Kay Chemical Company

    8300 Capital Drive • Greensboro, NC 27409

    Made in USA

    CSUSA 778257/8000/0621

    representative label

  • INGREDIENTS AND APPEARANCE
    CHEMSTAR RETAIL HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-314
    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
    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:63146-314-091200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/27/2021
    Labeler - Kay Chemical Company (003237021)
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