Active Ingredient(s)

Ethyl Alcohol 75% v/

Purpose

Antiseptic

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

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

Do not use

in children less than 2 months of age
on open skin wounds

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Water, C10 30 alkyl acrylate crosspolymer, aminomethyl propanol, glycerin, aloe barbadensis (leaf)extract

Package Label - Principal Display Panel

HAND SANITIZER
hand sanitizer gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78126-007
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
GLYCERIN (UNII: PDC6A3C0OX)	0.5 mL in 100 mL
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)	0.4 mL in 100 mL
WATER (UNII: 059QF0KO0R)	24.05 mL in 100 mL
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)	0.04 mL in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.01 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78126-007-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:78126-007-02	25 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:78126-007-03	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:78126-007-04	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:78126-007-05	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC:78126-007-06	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:78126-007-07	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC:78126-007-08	73 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC:78126-007-09	80 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC:78126-007-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC:78126-007-11	106 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
12	NDC:78126-007-12	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
13	NDC:78126-007-13	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
14	NDC:78126-007-14	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
15	NDC:78126-007-15	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
16	NDC:78126-007-16	207 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
17	NDC:78126-007-17	220 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
18	NDC:78126-007-18	221 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
19	NDC:78126-007-19	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
20	NDC:78126-007-20	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
21	NDC:78126-007-21	296 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
22	NDC:78126-007-22	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
23	NDC:78126-007-29	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
24	NDC:78126-007-23	350 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
25	NDC:78126-007-24	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
26	NDC:78126-007-25	400 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
27	NDC:78126-007-26	444 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
28	NDC:78126-007-27	450 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
29	NDC:78126-007-28	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
30	NDC:78126-007-30	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
31	NDC:78126-007-31	550 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
32	NDC:78126-007-32	800 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
33	NDC:78126-007-33	999 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
34	NDC:78126-007-34	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
35	NDC:78126-007-35	1479 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
36	NDC:78126-007-36	2000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
37	NDC:78126-007-37	2500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
38	NDC:78126-007-38	3000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
39	NDC:78126-007-39	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
40	NDC:78126-007-40	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
41	NDC:78126-007-41	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
42	NDC:78126-007-42	7571 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
43	NDC:78126-007-43	25000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
44	NDC:78126-007-44	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 - GUANGZHOU RAINHOME PHARM&TECH CO., LTD (547018779)

Name	Address	ID/FEI	Business Operations
Establishment
GUANGZHOU RAINHOME PHARM&TECH CO., LTD		547018779	manufacture(78126-007)