PUROMA ANTIBACTERIAL FOAMING HAND WASH WITH FRAGRANCE ALCOHOL FREE CITRUS FLORAL- benzalkonium chloride liquid

PUROMA Antibacterial Foaming Hand Wash With Fragrance alcohol Free citrus floral by

Drug Labeling and Warnings

PUROMA Antibacterial Foaming Hand Wash With Fragrance alcohol Free citrus floral 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

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.

Other information

Store below 104°F (40°C)

Inactive ingredient

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, PEG-12 Dimethicone , FD&C Blue NO. 1, Fragrance Fresh Citrus Floral ORC1501495.

Product label

INGREDIENTS AND APPEARANCE

PUROMA ANTIBACTERIAL FOAMING HAND WASH WITH FRAGRANCE ALCOHOL FREE CITRUS FLORAL 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80948-014
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)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80948-014-01	4 in 1 PACKAGE	04/23/2021
1		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 80948-014-02	6 in 1 PACKAGE	04/23/2021
2		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 80948-014-03	8 in 1 PACKAGE	04/23/2021
3		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 80948-014-04	12 in 1 PACKAGE	04/23/2021
4		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 80948-014-05	24 in 1 PACKAGE	04/23/2021
5		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 80948-014-06	4 in 1 PACKAGE	04/23/2021
6		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 80948-014-07	6 in 1 PACKAGE	04/23/2021
7		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 80948-014-08	8 in 1 PACKAGE	04/23/2021
8		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 80948-014-09	12 in 1 PACKAGE	04/23/2021
9		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 80948-014-10	24 in 1 PACKAGE	04/23/2021
10		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 80948-014-11	4 in 1 PACKAGE	04/23/2021
11		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 80948-014-12	6 in 1 PACKAGE	04/23/2021
12		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 80948-014-13	8 in 1 PACKAGE	04/23/2021
13		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 80948-014-14	12 in 1 PACKAGE	04/23/2021
14		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 80948-014-15	24 in 1 PACKAGE	04/23/2021
15		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 80948-014-16	4 in 1 PACKAGE	04/23/2021
16		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 80948-014-17	6 in 1 PACKAGE	04/23/2021
17		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC: 80948-014-18	8 in 1 PACKAGE	04/23/2021
18		200 mL in 1 PACKAGE; Type 0: Not a Combination Product
19	NDC: 80948-014-19	12 in 1 PACKAGE	04/23/2021
19		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
20	NDC: 80948-014-20	24 in 1 PACKAGE	04/23/2021
20		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
21	NDC: 80948-014-21	4 in 1 PACKAGE	04/23/2021
21		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
22	NDC: 80948-014-22	6 in 1 PACKAGE	04/23/2021
22		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
23	NDC: 80948-014-23	8 in 1 PACKAGE	04/23/2021
23		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
24	NDC: 80948-014-24	12 in 1 PACKAGE	04/23/2021
24		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
25	NDC: 80948-014-25	24 in 1 PACKAGE	04/23/2021
25		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
26	NDC: 80948-014-26	2 in 1 PACKAGE	04/23/2021
26		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
27	NDC: 80948-014-27	4 in 1 PACKAGE	04/23/2021
27		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
28	NDC: 80948-014-28	6 in 1 PACKAGE	04/23/2021
28		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
29	NDC: 80948-014-29	8 in 1 PACKAGE	04/23/2021
29		250 mL in 1 PACKAGE; Type 0: Not a Combination Product
30	NDC: 80948-014-30	12 in 1 PACKAGE	04/23/2021
30		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
31	NDC: 80948-014-31	24 in 1 PACKAGE	04/23/2021
31		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
32	NDC: 80948-014-32	2 in 1 PACKAGE	04/23/2021
32		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
33	NDC: 80948-014-33	4 in 1 PACKAGE	04/23/2021
33		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
34	NDC: 80948-014-34	6 in 1 PACKAGE	04/23/2021
34		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
35	NDC: 80948-014-35	8 in 1 PACKAGE	04/23/2021
35		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
36	NDC: 80948-014-36	12 in 1 PACKAGE	04/23/2021
36		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
37	NDC: 80948-014-37	24 in 1 PACKAGE	04/23/2021
37		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
38	NDC: 80948-014-38	2 in 1 PACKAGE	04/23/2021	04/23/2021
38		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
39	NDC: 80948-014-39	4 in 1 PACKAGE	04/23/2021	04/23/2021
39		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
40	NDC: 80948-014-40	6 in 1 PACKAGE	04/23/2021	04/23/2021
40		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
41	NDC: 80948-014-41	8 in 1 PACKAGE	04/23/2021	04/23/2021
41		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
42	NDC: 80948-014-42	12 in 1 PACKAGE	04/23/2021	04/23/2021
42		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
43	NDC: 80948-014-43	24 in 1 PACKAGE	04/23/2021	04/23/2021
43		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
44	NDC: 80948-014-44	5000 mL in 1 CAN; Type 0: Not a Combination Product	04/23/2021
45	NDC: 80948-014-45	50000 mL in 1 CAN; Type 0: Not a Combination Product	04/23/2021
46	NDC: 80948-014-46	200000 mL in 1 DRUM; Type 0: Not a Combination Product	04/23/2021
47	NDC: 80948-014-47	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2021
48	NDC: 80948-014-48	2 in 1 PACKAGE	10/19/2021
48		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
49	NDC: 80948-014-49	4 in 1 PACKAGE	10/19/2021
49		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
50	NDC: 80948-014-50	6 in 1 PACKAGE	10/19/2021
50		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
51	NDC: 80948-014-51	8 in 1 PACKAGE	10/19/2021
51		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
52	NDC: 80948-014-52	12 in 1 PACKAGE	10/19/2021
52		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
53	NDC: 80948-014-53	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	04/23/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Establishment
Name	Address	ID/FEI	Business Operations
ZENITH MICRO CONTROL		915625571	manufacture(80948-014)