Protex Hand Sanitizer

Manufacturer
Parker Laboratories, Inc.
Effective date
2022-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:45:09

Label at a glance#

ProductProtex Hand Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

Overview

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Tentative Final Monograph for Health-care Antiseptic Drug Products Section 333.450

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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.

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

Store between 59-86°F (15-30°C)

Avoid freezing and excessive heat above 104F° (40°C).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Cocamidopropyl Betaine, Ethylhexylglycerin, Eucalyptus Oil, Lemon Fragrance, PEG-7 Glyceryl Cocoate, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Water

External use only

WARNINGS SECTION

For external use only.

proteX Foaming Hand Sanitizer Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel with Drug FactsPrincipal Display Panel with Drug FactsproteX ®

foaming hand sanitizer

ref 40-18

Kills 99.99% of bacteria in 15 seconds

Alcohol Free

Benzalkonium Chloride 0.13%

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.

Storage:

Store between 59-86° degrees Farenheit (15-30°C)

Avoid freezing and excessive heat above 104°F (40°C)

18 fl oz/550 ml

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30775-04030775-040-02, 30775-040-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
05a4b085-ca62-d92f-e063-6294a90a8322bca7b1b4-b2e9-382e-e053-2995a90a45062023-09-18WarningsExact identifier
spl set id: bca7b1b4-b2e9-382e-e053-2995a90a4506

Reported adverse events (FAERS/openFDA)#

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