ANTIBACTERIAL HAND SANITIZER gel

Antibacterial Hand Sanitizer by

Drug Labeling and Warnings

Antibacterial Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Guangzhou Oumiao Cosmetics Co. Ltd. , Guangzhou Oumiao Cosmetics Co. Ltd.    . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Ethyl Alcohol 75%.

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria on skin.

Warnings

1.Caution for thosewho are allergic to ethanol(alcohol).

2.Should be stored in a cool and dry place, away from fire.

3.For external use only.

DO NOT USE

When using this product

do not use in or near the eyes.In case of contact,rinse eyes thoroughly with water.Stop use and ask doctor if irritation or rash appears and lasts.Keep out of reach for children.lf swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

KEEP OUT OF REACH OF CHILDREN

Directions

Place enough Product.in your palm to thoroughly spread on both hands and rub into the skin until dry.

Children under 6 years of age should be supervised when using this product.

Other information

Store below 106°F.(40℃)

Inactive ingredients

AQUA,TRIETHANOLAMINE, PHENOXYETHANOL,CARBOMER,PEG-40 HYDROGENATED CASTOR OIL,AROMA

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL HAND SANITIZER 
antibacterial hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74761-001
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)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74761-001-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020
2	NDC: 74761-001-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020
3	NDC: 74761-001-03	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020
4	NDC: 74761-001-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020
5	NDC: 74761-001-05	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020
6	NDC: 74761-001-06	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020
7	NDC: 74761-001-07	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020
8	NDC: 74761-001-08	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020
9	NDC: 74761-001-09	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020
10	NDC: 74761-001-10	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/19/2020

Labeler - Guangzhou Oumiao Cosmetics Co. Ltd.  (529806412)

Registrant - Guangzhou Oumiao Cosmetics Co. Ltd.  (529806412)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Oumiao Cosmetics Co. Ltd.		529806412	manufacture(74761-001)