HYDRO KLEEN AF- benzalkonium chloride liquid 
Productive Practices

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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Hydro Kleen AF

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

Warnings

  • Do not use in or near the eyes

  • In case of contact with eyes, flush thoroughly with water

  • If ingested, consult with a physician

  • Keep out of range of children 2yrs of age or younger

Directions

Other Information

Do not freeze

Inactive Ingredients

Water, Polysorbate 20, Glycerin, Citric Acid, Butylene Glycol, Cocamidopropylamine Oxide, Sodium Hydroxide, Cocamidopropyl Betaine, Cetrimonium Chloride

Questions?

1-877-446-8088 • www.ProductivePractices.net

PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label

ALCOHOL-FREE

HYDROKLEENAF
HAND SANITIZER

ANTISEPTIC
ANTI-BACTIERIAL
DYE FREE
FRAGRANCE FREE

DISTRIBUTED BY

6.7 fl oz (200ml)

Principal Display Panel - 200 mL Bottle Label
HYDRO KLEEN AF 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69129-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.13 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Glycerin (UNII: PDC6A3C0OX)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Cocamidopropylamine Oxide (UNII: M4SL82J7HK)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69129-010-01200 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E07/31/2014
Labeler - Productive Practices (010122499)

Revised: 8/2014
Document Id: 23e9fa8e-7332-47dd-9129-93298029a6e7
Set id: 274f85c6-dc09-458d-838d-36c274ea1809
Version: 1
Effective Time: 20140801
 
Productive Practices