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Drug Facts
Pfp Polyclean Hand Sanitizer - Gel 68
FDA Label NDC 77034-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pfp Industries, Llc (a Global Enterprise) for the product Pfp Polyclean Hand Sanitizer - Gel 68 (NDC 77034-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient [s]
Ethyl Alcohol 68% v/v
Otc - 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.
Otc - Do Not Use
Do not use
•In children less than 2 months of age
•On open skin wounds
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - 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 Ammonium Polyacryloyldimethyl Taurate*, Fragrance, Glycerin, Hydrogen peroxide, Isopropyl
Alcohol, Sterile water, Ticacel*
*May or May Not Contain
Product Labeling
PfP INDUSTRIES LOT Number :
POLYClean Hand Sanitizer—GEL 68 MADE IN TEXAS
FLAMMABLE LIQUID
3
DOT: UN1170, II/III, Flammable Liquid,
n.o.s (contains ethanol) Percent Active
Ethyl Alcohol : 68% (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
* Please review the disclaimer below.
