ZOONO ALCOHOL FREE HAND SANITIZER- benzalkonium chloride solution
Zoono USA, LLC

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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Zoono Antiseptic Alcohol Free Hand Sanitizer

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Uses

For personal hand sanitizing and to reduce bacteria on the skin. Recommended for repeated use.

Warnings

For external use only. Do not use in eyes.

When using this product avoid contact with eyes. In case of eye contact flush eyes with water.

Stop use and ask a doctor if irritation and redness develop

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally to the hands and gently rub until dry.

Inactive Ingredients

Fragrances, Silica Complex 3-(Trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Water.

Questions?

Telephone: 1-844-966-6687 Monday through Friday 8:00am til 5:00pm EST

Zoono Alcohol Free Hand Sanitizer

typical label

ZOONO ALCOHOL FREE HAND SANITIZER
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69221-601
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69221-601-01	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2017	04/19/2021
2	NDC:69221-601-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/20/2017	04/19/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/20/2017	04/19/2021

Labeler - Zoono USA, LLC (073623478)

Registrant - Zoono USA, LLC (073623478)

Revised: 11/2021

Document Id: cffb232c-c888-4a5f-e053-2a95a90aa35d

Set id: 526cf041-4d6a-7438-e054-00144ff8d46c

Version: 6

Effective Time: 20211104

Zoono USA, LLC