Active Ingredient(s)

Ethyl Alcohol 75% v/v.

Purpose

Antimicrobial

Use

For handwashing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

in the eyses. In case of contact, rinse eyes thorooughly with water

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours

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

Directions

Wet hands thorooughly with product, briskly rub hands together until dry, supervise children under 6 years in the use of this product.

Other information

Store below 110F (43C)
May discolor certain fabrics

Inactive ingredients

Water, Glycerin, Carbomer, Triethanolamine, Tocopheryl Acetate,Aloe.

Package Label - Principal Display Panel

label

INSTANT HAND SANITIZER GEL
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78160-001
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE (UNII: V5VD430YW9)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78160-001-01	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:78160-001-02	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:78160-001-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:78160-001-04	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:78160-001-05	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC:78160-001-06	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:78160-001-07	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC:78160-001-08	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC:78160-001-09	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC:78160-001-10	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC:78160-001-11	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
12	NDC:78160-001-12	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
13	NDC:78160-001-13	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
14	NDC:78160-001-14	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
15	NDC:78160-001-15	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
16	NDC:78160-001-16	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
17	NDC:78160-001-17	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
18	NDC:78160-001-18	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
19	NDC:78160-001-19	240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
20	NDC:78160-001-20	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
21	NDC:78160-001-21	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
22	NDC:78160-001-22	350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
23	NDC:78160-001-23	400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
24	NDC:78160-001-24	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
25	NDC:78160-001-25	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
26	NDC:78160-001-26	2000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
27	NDC:78160-001-27	4000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
28	NDC:78160-001-28	5000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
29	NDC:78160-001-29	10000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
30	NDC:78160-001-30	15000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
31	NDC:78160-001-31	20000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
32	NDC:78160-001-32	25000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
33	NDC:78160-001-33	50000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
34	NDC:78160-001-34	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
35	NDC:78160-001-35	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
36	NDC:78160-001-36	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
37	NDC:78160-001-37	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
38	NDC:78160-001-38	10000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
39	NDC:78160-001-39	15000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
40	NDC:78160-001-40	20000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
41	NDC:78160-001-41	25000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
42	NDC:78160-001-42	50000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Skinact (028174338)

Name	Address	ID/FEI	Business Operations
Establishment
Huizhou Duomei Daily Necessites Co.,Ltd		554530153	manufacture(78160-001)

Instant Hand Sanitizer Gel