DailyMed - PUROMA FOAMING HAND ALCOHOL FREE FRAGRANCE FREE- benzalkonium chloride liquid

NDC Code(s): 80948-007-01, 80948-007-02, 80948-007-03, 80948-007-04, view more
80948-007-05, 80948-007-06, 80948-007-07, 80948-007-08, 80948-007-09, 80948-007-10, 80948-007-11, 80948-007-12, 80948-007-13, 80948-007-14, 80948-007-15, 80948-007-16, 80948-007-17, 80948-007-18, 80948-007-19, 80948-007-20, 80948-007-21, 80948-007-22, 80948-007-23, 80948-007-24, 80948-007-25, 80948-007-26, 80948-007-27, 80948-007-28, 80948-007-29, 80948-007-30, 80948-007-31, 80948-007-32, 80948-007-33, 80948-007-34, 80948-007-35, 80948-007-36, 80948-007-37, 80948-007-38, 80948-007-39, 80948-007-40, 80948-007-41, 80948-007-42, 80948-007-43, 80948-007-44, 80948-007-45, 80948-007-46, 80948-007-47, 80948-007-48, 80948-007-49, 80948-007-50, 80948-007-51, 80948-007-52, 80948-007-53, 80948-007-54, 80948-007-55, 80948-007-56, 80948-007-57, 80948-007-58, 80948-007-59, 80948-007-60, 80948-007-61, 80948-007-62, 80948-007-63, 80948-007-64, 80948-007-65, 80948-007-66, 80948-007-67, 80948-007-68, 80948-007-69, 80948-007-70, 80948-007-71, 80948-007-73, 80948-007-74
Packager: ZENITH MICRO CONTROL

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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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

• Put enough product in your palm to cover hands and rub hands together briskly for 30 seconds. Allow to dry.
• Children under 6 years of age should be supervised when using Puroma Hand Sanitizer.
Inactive ingredients

Water ( Aqua), Caprylyl Glycol, Coco Glucoside, Decyl Glucoside, PEG-12 Dimethicone, Cocoamidopropyl Betaine, Methylisothiozolinone, Methylchloro Isothiozolinone, Phenoxy Ethanol, Cetrimonium Chloride, Behentrimonium Chloride, Aloevera Leaf, PEG-7 Glyceril Cocoate, Betain, Polysorbate 20, Citric Acid, Glyceril Oleate , Glycerin, Propylene Glycol, Edetate Sodium.
Other information

• Store below 104°F (40°C)
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUROMA FOAMING HAND ALCOHOL FREE FRAGRANCE FREE
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80948-007
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)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE SODIUM (UNII: MP1J8420LU)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
COCO GLUCOSIDE (UNII: ICS790225B)
GLYCERYL OLEATE (UNII: 4PC054V79P)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
BEHENTRIMONIUM CHLORIDE (UNII: X7GNG3S47T)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BETAINE (UNII: 3SCV180C9W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80948-007-01	6 in 1 PACKAGE	03/10/2021
1		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:80948-007-02	8 in 1 PACKAGE	03/10/2021
2		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:80948-007-03	12 in 1 PACKAGE	03/10/2021	03/10/2021
3		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:80948-007-04	24 in 1 PACKAGE	03/10/2021	03/10/2021
4		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:80948-007-05	48 in 1 PACKAGE	03/10/2021	03/10/2021
5		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC:80948-007-06	4 in 1 PACKAGE	03/10/2021
6		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:80948-007-07	6 in 1 PACKAGE	03/10/2021
7		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:80948-007-08	8 in 1 PACKAGE	03/10/2021
8		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC:80948-007-09	12 in 1 PACKAGE	03/10/2021
9		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC:80948-007-10	24 in 1 PACKAGE	03/10/2021
10		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC:80948-007-11	48 in 1 PACKAGE	03/10/2021
11		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC:80948-007-12	4 in 1 PACKAGE	03/10/2021
12		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC:80948-007-13	6 in 1 PACKAGE	03/10/2021
13		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC:80948-007-14	8 in 1 PACKAGE	03/10/2021
14		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC:80948-007-15	12 in 1 PACKAGE	03/10/2021
15		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC:80948-007-16	24 in 1 PACKAGE	03/10/2021
16		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC:80948-007-17	48 in 1 PACKAGE	03/10/2021
17		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC:80948-007-18	4 in 1 PACKAGE	03/10/2021
18		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
19	NDC:80948-007-19	6 in 1 PACKAGE	03/10/2021
19		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
20	NDC:80948-007-20	8 in 1 PACKAGE	03/10/2021
20		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
21	NDC:80948-007-21	12 in 1 PACKAGE	03/10/2021
21		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
22	NDC:80948-007-22	24 in 1 PACKAGE	03/10/2021
22		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
23	NDC:80948-007-23	48 in 1 PACKAGE	03/10/2021
23		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
24	NDC:80948-007-24	2 in 1 PACKAGE	03/10/2021
24		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
25	NDC:80948-007-25	4 in 1 PACKAGE	03/10/2021
25		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
26	NDC:80948-007-26	6 in 1 PACKAGE	03/10/2021
26		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
27	NDC:80948-007-27	8 in 1 PACKAGE	03/10/2021
27		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
28	NDC:80948-007-28	12 in 1 PACKAGE	03/10/2021
28		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
29	NDC:80948-007-29	24 in 1 PACKAGE	03/10/2021
29		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
30	NDC:80948-007-30	2 in 1 PACKAGE	03/10/2021
30		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
31	NDC:80948-007-31	4 in 1 PACKAGE	03/10/2021
31		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
32	NDC:80948-007-32	6 in 1 PACKAGE	03/10/2021
32		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
33	NDC:80948-007-33	8 in 1 PACKAGE	03/10/2021
33		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
34	NDC:80948-007-34	12 in 1 PACKAGE	03/10/2021
34		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
35	NDC:80948-007-35	24 in 1 PACKAGE	03/10/2021
35		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
36	NDC:80948-007-36	2 in 1 PACKAGE	03/10/2021
36		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
37	NDC:80948-007-37	4 in 1 PACKAGE	03/10/2021
37		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
38	NDC:80948-007-38	6 in 1 PACKAGE	03/10/2021
38		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
39	NDC:80948-007-39	8 in 1 PACKAGE	03/10/2021
39		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
40	NDC:80948-007-40	12 in 1 PACKAGE	03/10/2021
40		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
41	NDC:80948-007-41	24 in 1 PACKAGE	03/10/2021
41		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
42	NDC:80948-007-42	2 in 1 PACKAGE	03/10/2021
42		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
43	NDC:80948-007-43	4 in 1 PACKAGE	03/10/2021
43		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
44	NDC:80948-007-44	6 in 1 PACKAGE	03/10/2021
44		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
45	NDC:80948-007-45	8 in 1 PACKAGE	03/10/2021
45		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
46	NDC:80948-007-46	12 in 1 PACKAGE	03/10/2021
46		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
47	NDC:80948-007-47	24 in 1 PACKAGE	03/10/2021
47		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
48	NDC:80948-007-48	2 in 1 PACKAGE	03/10/2021	03/10/2021
48		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
49	NDC:80948-007-49	4 in 1 PACKAGE	03/10/2021	03/10/2021
49		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
50	NDC:80948-007-50	6 in 1 PACKAGE	03/10/2021	03/10/2021
50		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
51	NDC:80948-007-51	8 in 1 PACKAGE	03/10/2021	03/10/2021
51		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
52	NDC:80948-007-52	12 in 1 PACKAGE	03/10/2021	03/10/2021
52		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
53	NDC:80948-007-53	24 in 1 PACKAGE	03/10/2021	03/10/2021
53		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
54	NDC:80948-007-54	2 in 1 PACKAGE	03/10/2021
54		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
55	NDC:80948-007-55	4 in 1 PACKAGE	03/10/2021
55		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
56	NDC:80948-007-56	6 in 1 PACKAGE	03/10/2021
56		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
57	NDC:80948-007-57	8 in 1 PACKAGE	03/10/2021
57		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
58	NDC:80948-007-58	12 in 1 PACKAGE	03/10/2021
58		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
59	NDC:80948-007-59	24 in 1 PACKAGE	03/10/2021
59		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
60	NDC:80948-007-60	5000 mL in 1 CAN; Type 0: Not a Combination Product	03/10/2021
61	NDC:80948-007-61	50000 mL in 1 CAN; Type 0: Not a Combination Product	03/10/2021
62	NDC:80948-007-62	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/10/2021
63	NDC:80948-007-63	70 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2021
64	NDC:80948-007-64	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/21/2021
65	NDC:80948-007-65	2 in 1 PACKAGE	10/21/2021
65		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
66	NDC:80948-007-66	4 in 1 PACKAGE	10/21/2021
66		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
67	NDC:80948-007-67	6 in 1 PACKAGE	10/21/2021
67		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
68	NDC:80948-007-68	8 in 1 PACKAGE	10/21/2021
68		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
69	NDC:80948-007-69	12 in 1 PACKAGE	10/21/2021
69		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
70	NDC:80948-007-70	24 in 1 PACKAGE	10/21/2021
70		300 mL in 1 BOTTLE; Type 0: Not a Combination Product
71	NDC:80948-007-71	12 in 1 PACKAGE	10/21/2021
71		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
72	NDC:80948-007-73	24 in 1 PACKAGE	10/21/2021
72		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
73	NDC:80948-007-74	48 in 1 PACKAGE	10/21/2021
73		60 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	03/10/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Name	Address	ID/FEI	Business Operations
Establishment
ZENITH MICRO CONTROL		915625571	manufacture(80948-007)

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Published Date (What is this?)	Version	Files
Dec 15, 2023	4 (current)	download
Mar 7, 2022	3	download
Mar 31, 2021	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1020365	benzalkonium chloride 0.13 % Topical Foam	PSN
2	1020365	benzalkonium chloride 1.3 MG/ML Topical Foam	SCD
3	1020365	benzalkonium chloride 0.13 % Topical Foam	SY

Label: PUROMA FOAMING HAND ALCOHOL FREE FRAGRANCE FREE- benzalkonium chloride liquid

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	NDC
1	80948-007-01
2	80948-007-02
3	80948-007-03
4	80948-007-04
5	80948-007-05
6	80948-007-06
7	80948-007-07
8	80948-007-08
9	80948-007-09
10	80948-007-10
11	80948-007-11
12	80948-007-12
13	80948-007-13
14	80948-007-14
15	80948-007-15
16	80948-007-16
17	80948-007-17
18	80948-007-18
19	80948-007-19
20	80948-007-20
21	80948-007-21
22	80948-007-22
23	80948-007-23
24	80948-007-24
25	80948-007-25
26	80948-007-26
27	80948-007-27
28	80948-007-28
29	80948-007-29
30	80948-007-30
31	80948-007-31
32	80948-007-32
33	80948-007-33
34	80948-007-34
35	80948-007-35
36	80948-007-36
37	80948-007-37
38	80948-007-38
39	80948-007-39
40	80948-007-40
41	80948-007-41
42	80948-007-42
43	80948-007-43
44	80948-007-44
45	80948-007-45
46	80948-007-46
47	80948-007-47
48	80948-007-48
49	80948-007-49
50	80948-007-50
51	80948-007-51
52	80948-007-52
53	80948-007-53
54	80948-007-54
55	80948-007-55
56	80948-007-56
57	80948-007-57
58	80948-007-58
59	80948-007-59
60	80948-007-60
61	80948-007-61
62	80948-007-62
63	80948-007-63
64	80948-007-64
65	80948-007-65
66	80948-007-66
67	80948-007-67
68	80948-007-68
69	80948-007-69
70	80948-007-70
71	80948-007-71
72	80948-007-73
73	80948-007-74

Label: PUROMA FOAMING HAND ALCOHOL FREE FRAGRANCE FREE- benzalkonium chloride liquid

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PUROMA FOAMING HAND ALCOHOL FREE FRAGRANCE FREE- benzalkonium chloride liquid

Number of versions: 3

PUROMA FOAMING HAND ALCOHOL FREE FRAGRANCE FREE- benzalkonium chloride liquid

PUROMA FOAMING HAND ALCOHOL FREE FRAGRANCE FREE- benzalkonium chloride liquid

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PUROMA FOAMING HAND ALCOHOL FREE FRAGRANCE FREE- benzalkonium chloride liquid

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.