HYDRO KLEEN AF- benzalkonium chloride liquid

Hydro Kleen AF by

Drug Labeling and Warnings

Hydro Kleen AF by is a Otc medication manufactured, distributed, or labeled by Productive Practices. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Uses

• Provide hand sanitizing when soap and water not available
• Kills or reduces 99.9% of harmful bacteria/germs
• Recommended for repeated use

Warnings

• For external use only

• 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

• Apply thumbnail size amount to palm
• Rub hands together thoroughly
• No rinsing required

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)

INGREDIENTS AND APPEARANCE

HYDRO KLEEN AF 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69129-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	0.13 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69129-010-01	200 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	07/31/2014

Labeler - Productive Practices (010122499)