ZOONO WOUND CLEANSER- benzalkonium chloride solution

Zoono Wound Cleanser by

Drug Labeling and Warnings

Zoono Wound Cleanser by is a Otc medication manufactured, distributed, or labeled by Zoono Holdings USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose:

Antiseptic

Uses:

Helps protect skin and supports healing

of minor cuts, scrapes, burns and wounds,

including pressure sores, diabetic ulcers,

cracked skin and lips. Topical antiseptic to help

decrease the risk of skin infections.

Warnings:

For external use only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with

eyes. In case of eye contact flush eyes with

water. Stop use and ask a doctor if condition

worsens, symptoms last more than 7 days or

clear up and occur again within a few days.

Keep out of reach of children. If swallowed, get medical help or contact a

Poison Control Center right away.

Inactive Ingredients:

Fragrances, Silica Complex

3-(Trimethoxysilyl) Propyl Dimethyl Octadecyl

Ammonium Chloride), Water.

Questions or Comments?

Telephone 1-844-966-6687

Monday through Friday

8:00am till 5:00pm EST

Directions:

Wound cleansing for adults and children 2

years of age or older: Spray the affected area

to clean dirt and debris, use a small amount of

the product and wipe it off with a sterile gauze.

For use as First Aid antiseptic for adults and

children years of age or older:

Clean the affected area. Spray a small amount of

this product on the area 1 to 3 times daily or as

needed. Wipe off excess with sterile gauze and

allow to dry. Cover affected area with a sterile

bandage if needed. When bandaged, let dry first

For children under 2 years of age please

consult a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZOONO WOUND CLEANSER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69221-204
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 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69221-204-02	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2016
2	NDC: 69221-204-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/23/2016
3	NDC: 69221-204-03	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/04/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/23/2016

Labeler - ZOONO USA, LLC (073623478)

Establishment
Name	Address	ID/FEI	Business Operations
Zoono USA, LLC		073623478	label(69221-204)