PUROMA ANTIBACTERIAL HAND WASH FRAGRANCE FREE- benzalkonium chloride liquid

PUROMA Antibacterial Hand Wash Fragrance Free by

Drug Labeling and Warnings

PUROMA Antibacterial Hand Wash Fragrance Free by is a Otc medication manufactured, distributed, or labeled by ZENITH MICRO CONTROL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antibacterial

Uses

Hand Sanitizer to help reduce bacteria on skin.

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, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Citric Acid Monohydrate, Phenoxyethanol, Edetate Sodium , Sodium Chloride, Decyl Glucoside, Coco Glucoside, Glyceril Oleate, Cocamidopropyl Betaine, Lauramine Oxide, Behentrimonium Chloride PEG-7 Glyceryl Cocoate, Cocamidopropyl Hydroxysultaine, Glycol Distearate, Polysorbate 20.

Other information

Store below 104°F (40°C)

Product label

INGREDIENTS AND APPEARANCE

PUROMA ANTIBACTERIAL HAND WASH FRAGRANCE FREE 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80948-006
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
GLYCERIN (UNII: PDC6A3C0OX)
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)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80948-006-01	4 in 1 PACKAGE	03/05/2021	03/05/2021
1		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 80948-006-02	6 in 1 PACKAGE	03/05/2021	03/05/2021
2		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 80948-006-03	8 in 1 PACKAGE	03/05/2021	03/05/2021
3		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 80948-006-04	12 in 1 PACKAGE	03/05/2021	03/05/2021
4		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC: 80948-006-05	24 in 1 PACKAGE	03/05/2021	03/05/2021
5		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC: 80948-006-06	2 in 1 PACKAGE	03/09/2021
6		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 80948-006-07	4 in 1 PACKAGE	03/09/2021
7		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 80948-006-08	6 in 1 PACKAGE	03/09/2021
8		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 80948-006-09	8 in 1 PACKAGE	03/09/2021
9		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 80948-006-10	12 in 1 PACKAGE	03/09/2021
10		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 80948-006-11	24 in 1 PACKAGE	03/09/2021
11		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 80948-006-12	2 in 1 PACKAGE	03/09/2021
12		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 80948-006-13	4 in 1 PACKAGE	03/09/2021
13		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 80948-006-14	6 in 1 PACKAGE	03/09/2021
14		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 80948-006-15	8 in 1 PACKAGE	03/09/2021
15		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 80948-006-16	12 in 1 PACKAGE	03/09/2021
16		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 80948-006-17	24 in 1 PACKAGE	03/09/2021
17		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC: 80948-006-18	2 in 1 PACKAGE	03/09/2021
18		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
19	NDC: 80948-006-19	4 in 1 PACKAGE	03/09/2021
19		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
20	NDC: 80948-006-20	6 in 1 PACKAGE	03/09/2021
20		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
21	NDC: 80948-006-21	8 in 1 PACKAGE	03/09/2021
21		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
22	NDC: 80948-006-22	12 in 1 PACKAGE	03/09/2021
22		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
23	NDC: 80948-006-23	24 in 1 PACKAGE	03/09/2021
23		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
24	NDC: 80948-006-24	2 in 1 PACKAGE	03/09/2021
24		947 mL in 1 BOTTLE; Type 0: Not a Combination Product
25	NDC: 80948-006-25	4 in 1 PACKAGE	03/09/2021
25		947 mL in 1 BOTTLE; Type 0: Not a Combination Product
26	NDC: 80948-006-26	5000 mL in 1 CAN; Type 0: Not a Combination Product	03/09/2021
27	NDC: 80948-006-27	50000 mL in 1 CAN; Type 0: Not a Combination Product	03/09/2021
28	NDC: 80948-006-28	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/09/2021
29	NDC: 80948-006-29	4 in 1 PACKAGE	10/19/2021
29		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
30	NDC: 80948-006-30	6 in 1 PACKAGE	10/19/2021
30		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
31	NDC: 80948-006-31	8 in 1 PACKAGE	10/19/2021
31		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
32	NDC: 80948-006-32	12 in 1 PACKAGE	10/19/2021
32		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
33	NDC: 80948-006-33	24 in 1 PACKAGE	10/19/2021
33		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
34	NDC: 80948-006-34	178 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
35	NDC: 80948-006-35	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
36	NDC: 80948-006-36	326 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
37	NDC: 80948-006-37	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
38	NDC: 80948-006-38	974 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	03/05/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Establishment
Name	Address	ID/FEI	Business Operations
ZENITH MICRO CONTROL		915625571	manufacture(80948-006)