Protex Hand Sanitizer by Parker Laboratories, Inc. Protex Hand Sanitizer

Protex Hand Sanitizer by

Drug Labeling and Warnings

Protex Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Parker Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROTEX HAND SANITIZER- foaming hand sanitizer liquid 
Parker Laboratories, Inc.

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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Protex Hand Sanitizer

Overview

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

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antiseptic, Hand Sanitizer

Use

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

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.

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 59-86°F (15-30°C)

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

Inactive ingredients

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

For external use only.

proteX Foaming Hand Sanitizer
Principal Display Panel

Principal 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

PROTEX HAND SANITIZER 
foaming hand sanitizer liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30775-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LEMON (UNII: 24RS0A988O)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
WATER (UNII: 059QF0KO0R)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
ALOE (UNII: V5VD430YW9)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 30775-040-0224 in 1 BOX03/31/2021
160 g in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 30775-040-182 in 1 BOX03/31/2021
28 in 1 BOX
2550 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/31/202106/01/2023
Labeler - Parker Laboratories, Inc. (931423607)
Establishment
NameAddressID/FEIBusiness Operations
Parker Laboratories, Inc.931423607manufacture(30775-040)

Revised: 9/2023