Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Uses

Helps eliminate bacteria on hands.

Warnings

• For external use only.
• When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
• Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children

except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands and wrists with clean running water.
Apply appropriate amount of product.
Lather and scrub hands, fingers, fingernails, cuticles and wrists thoroughly.
Rinse thoroughly with running water.
Dry hands completely.

Inactive ingredients

Water,Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Cetrimonium Chloride, Lauramidopropylamine Oxide , Coco Monoethanolamide, Propylene Glycol, Citric Acid Monohydrate, Phenoxyethanol, Edetate Sodium , Decyl Glucoside, Coco Glucoside, Glyceril Oleate, Cocamidopropyl Betaine, Lauramine Oxide, Behentrimonium Chloride, PEG-7 Glyceryl Cocoate, Cocamidopropyl Hydroxysultaine, Polysorbate 20, Sodium Chloride, FD&C Green No.3.

Other information

Store below 104°F (40°C)

Product label

image description

PUROMA ANTIBACTERIAL FOAMING HAND WASH FRAGRANCE FREE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80948-005
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	130 mg in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80948-005-01	4 in 1 PACKAGE	03/10/2021
1		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:80948-005-02	6 in 1 PACKAGE	03/10/2021
2		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:80948-005-03	8 in 1 PACKAGE	03/10/2021
3		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:80948-005-04	12 in 1 PACKAGE	03/10/2021
4		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:80948-005-05	24 in 1 PACKAGE	03/10/2021
5		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:80948-005-06	4 in 1 PACKAGE	03/10/2021
6		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:80948-005-07	6 in 1 PACKAGE	03/10/2021
7		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:80948-005-08	8 in 1 PACKAGE	03/10/2021
8		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:80948-005-09	12 in 1 PACKAGE	03/10/2021
9		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC:80948-005-10	24 in 1 PACKAGE	03/10/2021
10		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC:80948-005-11	4 in 1 PACKAGE	03/10/2021
11		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC:80948-005-12	6 in 1 PACKAGE	03/10/2021
12		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC:80948-005-13	8 in 1 PACKAGE	03/10/2021
13		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC:80948-005-14	12 in 1 PACKAGE	03/10/2021
14		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC:80948-005-15	24 in 1 PACKAGE	03/10/2021
15		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC:80948-005-21	4 in 1 PACKAGE	03/10/2021
16		200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
17	NDC:80948-005-22	6 in 1 PACKAGE	03/10/2021
17		200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
18	NDC:80948-005-23	8 in 1 PACKAGE	03/10/2021
18		200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
19	NDC:80948-005-24	12 in 1 PACKAGE	03/10/2021
19		200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
20	NDC:80948-005-25	24 in 1 PACKAGE	03/10/2021
20		200 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
21	NDC:80948-005-26	4 in 1 PACKAGE	03/10/2021
21		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
22	NDC:80948-005-27	6 in 1 PACKAGE	03/10/2021
22		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
23	NDC:80948-005-28	8 in 1 PACKAGE	03/10/2021
23		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
24	NDC:80948-005-29	12 in 1 PACKAGE	03/10/2021
24		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
25	NDC:80948-005-30	24 in 1 PACKAGE	03/10/2021
25		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
26	NDC:80948-005-31	2 in 1 PACKAGE	03/10/2021
26		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
27	NDC:80948-005-32	4 in 1 PACKAGE	03/10/2021
27		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
28	NDC:80948-005-33	6 in 1 PACKAGE	03/10/2021
28		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
29	NDC:80948-005-34	8 in 1 PACKAGE	03/10/2021
29		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
30	NDC:80948-005-35	12 in 1 PACKAGE	03/10/2021
30		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
31	NDC:80948-005-36	24 in 1 PACKAGE	03/10/2021
31		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
32	NDC:80948-005-37	2 in 1 PACKAGE	03/10/2021
32		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
33	NDC:80948-005-38	4 in 1 PACKAGE	03/10/2021
33		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
34	NDC:80948-005-39	6 in 1 PACKAGE	03/10/2021
34		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
35	NDC:80948-005-40	8 in 1 PACKAGE	03/10/2021
35		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
36	NDC:80948-005-41	12 in 1 PACKAGE	03/10/2021
36		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
37	NDC:80948-005-42	24 in 1 PACKAGE	03/10/2021
37		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
38	NDC:80948-005-43	2 in 1 PACKAGE	03/10/2021
38		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
39	NDC:80948-005-44	4 in 1 PACKAGE	03/10/2021
39		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
40	NDC:80948-005-45	6 in 1 PACKAGE	03/10/2021
40		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
41	NDC:80948-005-46	8 in 1 PACKAGE	03/10/2021
41		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
42	NDC:80948-005-47	12 in 1 PACKAGE	03/10/2021
42		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
43	NDC:80948-005-48	24 in 1 PACKAGE	03/10/2021
43		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
44	NDC:80948-005-49	5000 mL in 1 CAN; Type 0: Not a Combination Product	03/10/2021
45	NDC:80948-005-50	50000 mL in 1 CAN; Type 0: Not a Combination Product	03/10/2021
46	NDC:80948-005-51	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/10/2021
47	NDC:80948-005-52	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M003	03/10/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Name	Address	ID/FEI	Business Operations
Establishment
ZENITH MICRO CONTROL		915625571	manufacture(80948-005)