Label: DUDAS HAND SANITIZER GEL- alcohol gel

  • 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 January 27, 2022

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  • Active Ingredient(s)

    1 Gallon

  • Purpose

    sanitizer

  • Use

    image

  • Warnings

    warnings

  • KEEP OUT OF REACH OF CHILDREN

    children

  • Inactive ingredients

    = inactive

  • DOSAGE & ADMINISTRATION

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • STORAGE AND HANDLING

    • store in a well-ventilated place and keep cool.
  • Package Label - Principal Display Panel

    package label

    5 gallon950 ml

  • INGREDIENTS AND APPEARANCE
    DUDAS HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77209-9664
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 2.5 L  in 100 L
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) 1.1 L  in 100 L
    WATER (UNII: 059QF0KO0R)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77209-9664-10.95 L in 1 BOTTLE; Type 0: Not a Combination Product05/08/2020
    2NDC:77209-9664-23.785 L in 1 JUG; Type 0: Not a Combination Product05/08/2020
    3NDC:77209-9664-318.9 L in 1 PAIL; Type 0: Not a Combination Product05/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/08/2020
    Labeler - Duda Energy LLC (023793705)
    Registrant - Duda Energy LLC (023793705)
    Establishment
    NameAddressID/FEIBusiness Operations
    Duda Energy LLC023793705label(77209-9664) , pack(77209-9664) , manufacture(77209-9664)
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