HAND SANITIZER GEL 75% ALCOHOL- alcohol gel

Hand Sanitizer Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

• Flammable.Keep away from fire or flame
• For external use only
• 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 a doctor if irritation or rash appears and lasts

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Place enough product in your palm to cover hands and rub hands together briskly until dry
• Children under 6 years of age should be supervised when using this product

Other information

• Do not store above 104 F (40 C)

Inactive ingredients

Ethyl Alcohol, Aqua, Glycerin, Acrylates/c10-30 Alkyl Acrylate Crosspolymer, Tetrahydroxypropyl Ethylenediamine, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HAND SANITIZER GEL  75% ALCOHOL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74168-003
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)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETOL (UNII: Q4R969U9FR)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74168-003-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
2	NDC: 74168-003-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
3	NDC: 74168-003-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
4	NDC: 74168-003-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
5	NDC: 74168-003-05	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
6	NDC: 74168-003-06	90 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
7	NDC: 74168-003-07	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
8	NDC: 74168-003-08	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
9	NDC: 74168-003-09	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
10	NDC: 74168-003-10	180 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
11	NDC: 74168-003-11	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
12	NDC: 74168-003-12	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
13	NDC: 74168-003-13	50 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
14	NDC: 74168-003-14	100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
15	NDC: 74168-003-15	200 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
16	NDC: 74168-003-16	250 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
17	NDC: 74168-003-17	200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
18	NDC: 74168-003-18	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
19	NDC: 74168-003-19	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
20	NDC: 74168-003-20	480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
21	NDC: 74168-003-21	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
22	NDC: 74168-003-22	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
23	NDC: 74168-003-23	280 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
24	NDC: 74168-003-24	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
25	NDC: 74168-003-25	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
26	NDC: 74168-003-26	20 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
27	NDC: 74168-003-27	30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
28	NDC: 74168-003-28	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
29	NDC: 74168-003-29	236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
30	NDC: 74168-003-30	300 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
31	NDC: 74168-003-31	500 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/08/2020
32	NDC: 74168-003-32	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
33	NDC: 74168-003-33	750 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
34	NDC: 74168-003-34	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
35	NDC: 74168-003-35	1290 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
36	NDC: 74168-003-36	1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
37	NDC: 74168-003-37	2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
38	NDC: 74168-003-38	2500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
39	NDC: 74168-003-39	3000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
40	NDC: 74168-003-40	3780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
41	NDC: 74168-003-41	4000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
42	NDC: 74168-003-42	5000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	04/08/2020
43	NDC: 74168-003-43	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
44	NDC: 74168-003-44	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
45	NDC: 74168-003-45	2500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
46	NDC: 74168-003-46	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
47	NDC: 74168-003-47	6000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
48	NDC: 74168-003-48	10000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
49	NDC: 74168-003-49	12500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
50	NDC: 74168-003-50	15000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
51	NDC: 74168-003-51	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
52	NDC: 74168-003-52	25000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
53	NDC: 74168-003-53	28000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020
54	NDC: 74168-003-54	30000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/08/2020

Labeler - Zhejiang Yasili Cosmetics Co. Ltd (530934090)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Yasili Cosmetics Co. Ltd		530934090	manufacture(74168-003)