PATRIOT HAND SANITIZER GALLON- hand sanitizer gel 
DFMPRINTPAK3709

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.

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Inactive Ingredients

Inactive Ingredeints for this product are:

Glycerin

Aloe Barbadensis Leaf Extract

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 is Ethyl Alcohol 77%

Hand Sanitizer Active Ingredient

Ethyl Alcohol 77%

Package Label Principal Display

Gallon Label

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)

Revised: 6/2020
Document Id: a743bd42-bc1b-f0d5-e053-2995a90a8a9b
Set id: a4e9a3ad-3491-68ef-e053-2995a90a9f30
Version: 4
Effective Time: 20200604
 
DFMPRINTPAK3709