PFP POLYCLEANE HAND SANITIZER - GEL 70- gel hand sanitizer gel 
Pfp Industries, LLC (a Global Enterprise)

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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PFP POLYcleanE Hand Sanitizer - Gel 70

Drug Facts

Active ingredient [s]
Ethyl Alcohol 70% v/v

Purpose
Antiseptic

Use [s]
Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings
For external use only. Flammable. Keep away from heat or flame.

Do not use
•In children less than 2 months of age
•On open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions
•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.

Other Information
•Store between 15-30C (59-86F)
•Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients Glycerin, Sterile Water, Ammonium Polyacryloyldimethyl Taurate, Vitamin E(DL=alpha tocopherol), iso-propyl Myristate, Fragrance

Product Labeling

PfP INDUSTRIES                                   LOT Number :

POLYCleanE Hand Sanitizer—GEL 70                                 MADE IN TEXAS

FLAMMABLE LIQUID

            3

DOT: UN1170, II/III, Flammable Liquid,
n.o.s (contains ethanol) Percent Active
Ethyl Alcohol : 70% (v/v)

Before handling this material, read ac-
companied Safety Data Sheet for more
detailed safety, health and environmen-
tal data.

Net Vol : 325 gal

Address : PFP Industries LLC

34011 Sunset lane Brookshire TX 77423
Ph: 281 371 2000

009-01 325Gal

res 8.22.20

PFP POLYCLEANE HAND SANITIZER - GEL 70 
gel hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77034-009
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 L  in 100 L
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77034-009-011217 L in 1 CONTAINER; Type 0: Not a Combination Product07/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/23/2020
Labeler - Pfp Industries, LLC (a Global Enterprise) (080458439)

Revised: 1/2021
Document Id: 28480693-514c-437d-9a13-91f9ac260353
Set id: 21763007-6dc6-4df1-9ffe-90d9c7948567
Version: 1
Effective Time: 20210113
 
Pfp Industries, LLC (a Global Enterprise)