CERTUS SECURE HAND SANITIZER- benzethonium chloride liquid

Certus Secure Hand Sanitizer by

Drug Labeling and Warnings

Certus Secure Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Certus Medical, Inc., ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Box OTC-Active Ingredient Section

BENZETHONIUM CHLORIDE 0.2%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

For hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

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

Drug Facts Box OTC-Dosage & Administration Section

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

rub hands together until dry

wash hands with soap and water at earliest opportunity

Drug Facts Box OTC-Inactive Ingredient Section

water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, fragrance

Certus Secure Hand Sanitizer

Certus Secure Hand Sanitizer

INGREDIENTS AND APPEARANCE

CERTUS SECURE HAND SANITIZER 
benzethonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75990-637
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75990-637-06	1 in 1 BOX	03/27/2017
1		800 mL in 1 BAG; Type 0: Not a Combination Product
2	NDC: 75990-637-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2017
3	NDC: 75990-637-24	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2017
4	NDC: 75990-637-01	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/27/2017
5	NDC: 75990-637-03	350 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/27/2017
6	NDC: 75990-637-05	540 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2017
7	NDC: 75990-637-07	700 mL in 1 BAG; Type 0: Not a Combination Product	03/27/2017
8	NDC: 75990-637-09	2000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/27/2017
9	NDC: 75990-637-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/27/2017
10	NDC: 75990-637-11	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2017
11	NDC: 75990-637-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/27/2017
12	NDC: 75990-637-13	800 mL in 1 BAG; Type 0: Not a Combination Product	03/27/2017
13	NDC: 75990-637-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2017
14	NDC: 75990-637-15	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2017
15	NDC: 75990-637-28	149 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2017
16	NDC: 75990-637-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	03/27/2017
17	NDC: 75990-637-55	208200 mL in 1 DRUM; Type 0: Not a Combination Product	03/27/2017
18	NDC: 75990-637-08	1 in 1 BOX	03/27/2017
18		1000 mL in 1 BAG; Type 0: Not a Combination Product
19	NDC: 75990-637-16	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2017
20	NDC: 75990-637-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/27/2017
21	NDC: 75990-637-19	18900 mL in 1 CONTAINER; Type 0: Not a Combination Product	03/27/2017
22	NDC: 75990-637-20	75600 mL in 1 DRUM; Type 0: Not a Combination Product	03/27/2017
23	NDC: 75990-637-35	132500 mL in 1 DRUM; Type 0: Not a Combination Product	03/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/27/2017

Labeler - Certus Medical, Inc. (966433653)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(75990-637)