Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 May 18, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol, 70% v/v

    Purpose

    Antimicrobial

  • Uses

    • Hand sanitizer, alcohol-based, used to kill bacteria in order to prevent diseases.
    • Ready to be used, as often as needed.
  • Warnings

    For external use only
    Flammable. Keep away from fire or flame

    Do not use

    near the eyes. In case of contact, rinse thoroughly with waterIf irritation develops, discontinue use and ask doctor.

    Keep out of reach of children.

    If swallowed, get medical help or call a Poison Control Center immediately

  • Directions

    • Place a small amount in your hands and rub together until dry.
    • No rinsing required.
  • Inactive ingredients

    Glycerin, Polyacrylic acid.

  • Questions or comments?

    feedback@grupodyasa.com

  • Package Labeling: 33.81oz/1L

    Bottle

  • Package Labeling: 1Gallon/3.785L

    Bottle2

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77357-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77357-000-011 L in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    2NDC:77357-000-023.785 L in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/24/2020
    Labeler - Desmoldantes y Aditivos, S.A. de C.V. (812364628)
    Establishment
    NameAddressID/FEIBusiness Operations
    Desmoldantes y Aditivos, S.A. de C.V.812364628manufacture(77357-000)
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