Active Ingredient(s)

Benzalkonium Chloride 0.1% Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

to decrease bacteria on the skin that could cause disease

Warnings

For external use only-hands

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

if skin irritation develops.

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

Directions

Rub thoroughly over all the surfaces of both hands.
Rub hands together briskly until dry.

Inactive ingredients

glycerol, purified water USP

Package Label - Principal Display Panel

100 mL NDC: 75446-111-14

MEDSHIELD PRODUCTS
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75446-111
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1 ug in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:75446-111-04	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
2	NDC:75446-111-06	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
3	NDC:75446-111-08	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
4	NDC:75446-111-10	75 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
5	NDC:75446-111-12	80 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
6	NDC:75446-111-14	100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
7	NDC:75446-111-16	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
8	NDC:75446-111-18	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
9	NDC:75446-111-20	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
10	NDC:75446-111-22	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
11	NDC:75446-111-24	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
12	NDC:75446-111-26	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
13	NDC:75446-111-28	1183 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
14	NDC:75446-111-30	1892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
15	NDC:75446-111-32	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
16	NDC:75446-111-34	10000000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
17	NDC:75446-111-36	12000000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020
18	NDC:75446-111-02	18 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/27/2020

Labeler - HWL Holdings, LLC (058630887)

Name	Address	ID/FEI	Business Operations
Establishment
HWL Holdings, LLC		058630887	manufacture(75446-111)