PFP POLYCLEAN HAND SANITIZER - GEL 80- gel hand sanitizer gel

PFP POLYclean Hand Sanitizer - Gel 80 by

Drug Labeling and Warnings

PFP POLYclean Hand Sanitizer - Gel 80 by is a Otc medication manufactured, distributed, or labeled by Pfp Industries, LLC (a Global Enterprise). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient [s]
Ethyl Alcohol 80% v/v

PURPOSE

Purpose
Antiseptic

INDICATIONS & USAGE

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

WARNINGS

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

DO NOT USE

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

WHEN USING

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

STOP USE

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

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

DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

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

INACTIVE INGREDIENT

Inactive ingredients Glycerin, IPA, Hydrogen Peroxide, Sterile Water, Ticacel*, Ammonium Polyacryloyldimethyl Taurate*, Fragrance

*May or May Not Contain

Product Labeling

PfP INDUSTRIES                                   LOT Number :

POLYClean Hand Sanitizer—GEL 80                               MADE IN TEXAS

FLAMMABLE LIQUID

            3

DOT: UN1170, II/III, Flammable Liquid,
n.o.s (contains ethanol) Percent Active
Ethyl Alcohol : 80% (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

res 8.22.20

INGREDIENTS AND APPEARANCE

PFP POLYCLEAN HAND SANITIZER - GEL 80 
gel hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77034-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
May contain	METHYLCELLULOSE (25 MPA.S) (UNII: BI55GG2WLI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77034-007-01	1217 L in 1 TANK; Type 0: Not a Combination Product	07/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/23/2020

Labeler - Pfp Industries, LLC (a Global Enterprise) (080458439)