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, 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, Polysorbate 20,FD&C Yellow 6, FD&C Red 40 , PEG-12 Dimethicone ,Fragrance Lavender Rose ORC1004596.

Other information

• Store below 104°F (40°C)

Product label

image description

PUROMA ANTIBACTERIAL HAND WASH WITH FRAGRANCE LAVENDER ROSE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80948-015
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
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FRAGRANCE LAVENDER ROSE ORC1004596 (UNII: 1XW43TV4PI)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80948-015-01	4 in 1 PACKAGE	03/05/2021	03/05/2021
1		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:80948-015-02	6 in 1 PACKAGE	04/24/2021	04/24/2021
2		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:80948-015-03	8 in 1 PACKAGE	04/24/2021	04/24/2021
3		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:80948-015-04	12 in 1 PACKAGE	04/24/2021	04/24/2021
4		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:80948-015-05	24 in 1 PACKAGE	04/24/2021	04/24/2021
5		178 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC:80948-015-06	2 in 1 PACKAGE	04/24/2021
6		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:80948-015-07	4 in 1 PACKAGE	04/24/2021
7		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:80948-015-08	6 in 1 PACKAGE	04/24/2021
8		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:80948-015-09	8 in 1 PACKAGE	04/24/2021
9		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC:80948-015-10	12 in 1 PACKAGE	04/24/2021
10		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC:80948-015-11	24 in 1 PACKAGE	04/24/2021
11		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC:80948-015-12	2 in 1 PACKAGE	04/24/2021
12		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC:80948-015-13	4 in 1 PACKAGE	04/24/2021
13		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC:80948-015-14	6 in 1 PACKAGE	04/24/2021
14		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC:80948-015-15	8 in 1 PACKAGE	04/24/2021
15		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC:80948-015-16	12 in 1 PACKAGE	04/24/2021
16		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC:80948-015-17	24 in 1 PACKAGE	04/24/2021
17		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC:80948-015-18	2 in 1 PACKAGE	04/24/2021
18		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
19	NDC:80948-015-19	4 in 1 PACKAGE	04/24/2021
19		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
20	NDC:80948-015-20	6 in 1 PACKAGE	04/24/2021
20		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
21	NDC:80948-015-21	8 in 1 PACKAGE	04/24/2021
21		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
22	NDC:80948-015-22	12 in 1 PACKAGE	04/24/2021
22		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
23	NDC:80948-015-23	24 in 1 PACKAGE	04/24/2021
23		474 mL in 1 BOTTLE; Type 0: Not a Combination Product
24	NDC:80948-015-24	2 in 1 PACKAGE	04/24/2021
24		947 mL in 1 BOTTLE; Type 0: Not a Combination Product
25	NDC:80948-015-25	4 in 1 PACKAGE	04/24/2021
25		947 mL in 1 BOTTLE; Type 0: Not a Combination Product
26	NDC:80948-015-26	5000 mL in 1 CAN; Type 0: Not a Combination Product	04/24/2021
27	NDC:80948-015-27	50000 mL in 1 CAN; Type 0: Not a Combination Product	04/24/2021
28	NDC:80948-015-28	200000 mL in 1 DRUM; Type 0: Not a Combination Product	04/24/2021
29	NDC:80948-015-29	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2021
30	NDC:80948-015-30	474 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2021
31	NDC:80948-015-31	4 in 1 PACKAGE	10/19/2021
31		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
32	NDC:80948-015-32	6 in 1 PACKAGE	10/19/2021
32		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
33	NDC:80948-015-33	8 in 1 PACKAGE	10/19/2021
33		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
34	NDC:80948-015-34	12 in 1 PACKAGE	10/19/2021
34		178 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - ZENITH MICRO CONTROL (915625571)

Name	Address	ID/FEI	Business Operations
Establishment
ZENITH MICRO CONTROL		915625571	manufacture(80948-015)