Label: PATRIOT HAND SANITIZER GALLON- hand sanitizer 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 June 4, 2020

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  • Inactive Ingredients

    Inactive Ingredeints for this product are:

    Glycerin

    Aloe Barbadensis Leaf Extract

  • KEEP OUT OF REACH OF CHILDREN

    Keep Product out of reach of children.

  • Indications and Use

    Indications and Use for this product:

    Wet hands thoroughly with product and allow to dry without wiping.

  • OTC Purpose

    Purpose of this product is to use for hand washing to decrease bacteria

    on the skin only when water is unavailable.

  • Dosage and Administration Section

    Dosage is a small amount of gel into palm of hands,

    to be rubbed into hands.

  • Warnings Section

    Warnings Section:

    Do not ingest product, for external use only.

    Flammable, keep away from fire and flames,

    See attached product label

    Patriot Sanitizer Label FINAL ART.jpg

  • Rinse will water if redness occurs

  • ACTIVE INGREDIENT

    Active Ingredient is Ethyl Alcohol 77%

  • Hand Sanitizer Active Ingredient

    Ethyl Alcohol 77%

  • Package Label Principal Display

    Gallon Label

  • INGREDIENTS AND APPEARANCE
    PATRIOT HAND SANITIZER GALLON 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75795-499
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2914.76 mL  in 3785.4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 773.17 mL  in 3785.4 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 37.85 mL  in 3785.4 mL
    GLYCERIN (UNII: PDC6A3C0OX) 59.62 mL  in 3785.4 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75795-499-013785.4 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
    2NDC:75795-499-16473.18 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2020
    3NDC:75795-499-08236.59 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2020
    4NDC:75795-499-04118.3 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2020
    5NDC:75795-499-0259.15 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/31/2020
    Labeler - DFMPRINTPAK3709 (106010016)
    Establishment
    NameAddressID/FEIBusiness Operations
    DFM Print Pak106010016manufacture(75795-499)
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