HAND SANITIZER by GUANGZHOU XUELEI COSMETIC CO.,LTD. HAND SANITIZER gel

HAND SANITIZER by

Drug Labeling and Warnings

HAND SANITIZER by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU XUELEI COSMETIC CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Alcohol（75% v//v）

Purpose

Antiseptic

Uses

help decrease bacteria on the hands

Warnings

For external use only.

Flammable. Keep away from fire or flame. Do not store in car.

Avoid contact with eyes, in case of contact, rinse eyes thoroughly with water immediately

Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center right away.

If irritation develops, discontinue use and consult a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children except under adult supervision. If swallowed, get medical help or contact a poison control center right away.

Directions

Wet hands thoroughly with product and rub lightly until dry. Do not wipe off or rinse.

Other Information

May discolor fabrics or surfaces. Store below 95 °F (35 ° C).

Inactive ingredients

Carbomer, Denatonium Benzoate, Purified Water USP, Tert-butyl Alcohol, Triethanolamine.

PRINCIPAL DISPLAY PANEL

50ml NDC: 74658-010-01

60ml NDC: 74658-010-02

236ml NDC: 74658-010-03

250ml NDC: 74658-010-04

260ml NDC: 74658-010-05

300ml NDC: 74658-010-06

500ml NDC: 74658-010-07

1000ml NDC: 74658-010-08

5000ml NDC: 74658-010-09

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74658-010
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)	22.1937 g  in 100 mL
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)	0.0809 g  in 100 mL
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)	0.4 g  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.22 g  in 100 mL
DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)	0.0004 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74658-010-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020
2	NDC: 74658-010-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020
3	NDC: 74658-010-03	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020
4	NDC: 74658-010-04	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020
5	NDC: 74658-010-05	260 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020
6	NDC: 74658-010-06	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020
7	NDC: 74658-010-07	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/02/2020
8	NDC: 74658-010-08	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/02/2020
9	NDC: 74658-010-09	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/02/2020

Labeler - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)

Registrant - GUANGZHOU XUELEI COSMETIC CO.,LTD. (526885026)

Establishment
Name	Address	ID/FEI	Business Operations
GUANGZHOU XUELEI COSMETIC CO.,LTD.		526885026	manufacture(74658-010) , pack(74658-010) , label(74658-010)