Hand Sanitizer

Active Ingredient(s)

Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

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

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 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.

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

HAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:77451-301
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:77451-301-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:77451-301-02	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:77451-301-03	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
4	NDC:77451-301-04	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
5	NDC:77451-301-05	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
6	NDC:77451-301-06	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
7	NDC:77451-301-07	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
8	NDC:77451-301-08	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
9	NDC:77451-301-09	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
10	NDC:77451-301-10	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
11	NDC:77451-301-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
12	NDC:77451-301-12	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
13	NDC:77451-301-13	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
14	NDC:77451-301-14	1200 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
15	NDC:77451-301-15	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
16	NDC:77451-301-16	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
17	NDC:77451-301-17	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
18	NDC:77451-301-18	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
19	NDC:77451-301-19	25000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
20	NDC:77451-301-20	25000 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 - Jewellery Time Limited (664342242)

Name	Address	ID/FEI	Business Operations
Establishment
Jewellery Time Limited		664342242	manufacture(77451-301)