PFP POLYclean Hand Sanitizer - Gel 68

Manufacturer
Pfp Industries, LLC (a Global Enterprise)
Effective date
2020-08-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:25:34

Label at a glance#

ProductPFP POLYclean Hand Sanitizer - Gel 68
Active ingredientALCOHOL
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient [s]
Ethyl Alcohol 68% v/v

OTC - PURPOSE SECTION

Purpose
Antiseptic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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 SECTION

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 SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

Inactive ingredients Ammonium Polyacryloyldimethyl Taurate*, Fragrance, Glycerin, Hydrogen peroxide, Isopropyl

Alcohol, Sterile water, Ticacel*

*May or May Not Contain

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

005 Gel 68005 Gel 68

res 8.22.20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1037039ethanol 68 % Topical GelPSN1
1037039ethanol 0.68 ML/ML Topical GelSCD1
1037039ethanol 68 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77034-005-012023-01-30C16284748780-1f386c649-cb92-0266-e053-dadaa90a7c1aPFP POLYclean Hand Sanitizer - Gel 68

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77034-005-01PFP POLYclean Hand Sanitizer - Gel 681217 L in 1 TANKGEL12171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77034-005PFP POLYCLEAN HAND SANITIZER - GEL 68 (GEL HAND SANITIZER) GEL [PFP INDUSTRIES, LLC (A GLOBAL ENTERPRISE)]1Legacy NDC, 1 package rows20200823_bb42c3e9-11ce-4b05-a0b1-69a8d198b268.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77034-00577034-005-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9004d4f0-239a-4873-9d76-b341c39a0d26bb42c3e9-11ce-4b05-a0b1-69a8d198b2682020-08-22WarningsExact identifier
spl id: 9004d4f0-239a-4873-9d76-b341c39a0d26
spl set id: bb42c3e9-11ce-4b05-a0b1-69a8d198b268

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.