OZLAB HAND SANITIZER- alcohol spray

OZLAB Hand Sanitizer by

Drug Labeling and Warnings

OZLAB Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Zhejiang Ounuo Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                 

Alcohol                75% (w/w)  

PURPOSE

Purpose - Antiseptic

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

For sanitizing and hand washing to decrease bacteria on skin

WARNINGS

For external use only: hands
Flammable. Keep away from heat, fire or spark, and electical.

Do not use near eyes. In case of contact, rinse eyes thoroughly with water Do not inhale or ingest.

Stop using and ask a doctor, if irritation or rash develops.

DOSAGE & ADMINISTRATION

Directions - Spray on palm generously (8-12 spprays), rub hands together and wet hands thoroughly with product. Allow at least 15 seconds for the product to kill germs.

INACTIVE INGREDIENT

Water (aqua), propylene glycol, Glycerin, Tocpheryl Acetate, fragrance (parfum)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OZLAB HAND SANITIZER 
alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75531-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	alcohol	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75531-004-01	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/28/2020
2	NDC: 75531-004-02	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/28/2020

Labeler - Zhejiang Ounuo Cosmetics Co., Ltd. (551868984)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ounuo Cosmetics Co., Ltd.		551868984	manufacture(75531-004)