Pro1Tek Antiseptic Foam Hand Sanitizer

Drug Labeling and Warnings

Drug Details [pdf]

PRO1TEK ANTISEPTIC HAND SANITIZER- benzalkonium chloride aerosol, foam 
Priority Environmental Solutions, 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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Pro1Tek Antiseptic Foam Hand Sanitizer

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses:

  • For handwashing to decrease bacteria on the skin.
  • Recommended for repeated use.

Warnings:

For external use only. Do not use in the eyes.

Discontinue use if

irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Wet hands thoroghly with product and allow to dry without wiping.

Inactive Ingredients

cetrimonium chloride, citric acid, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, laurtrimonium chloride, potassium carbonate, water

Package Labeling:

image descriptionimage description

PRO1TEK ANTISEPTIC HAND SANITIZER 
benzalkonium chloride aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 52232-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
POTASSIUM CARBONATE (UNII: BQN1B9B9HA)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 52232-101-511 in 1 CASE02/20/201712/31/2018
1550 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC: 52232-101-5050 mL in 1 BOTTLE; Type 0: Not a Combination Product01/04/201612/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E01/04/201612/31/2018
Labeler - Priority Environmental Solutions, Inc. (827067880)

Revised: 9/2019
Document Id: 93c89c17-a64f-5bfa-e053-2995a90a48d6
Set id: 10528294-26cc-4771-8eef-ae75151a6e44
Version: 6
Effective Time: 20190930
 
Priority Environmental Solutions, Inc.