PUROMA HAND SANITIZER FRAGRANCE FREE- alcohol liquid

PUROMA Hand Sanitizer Fragrance Free by

Drug Labeling and Warnings

PUROMA Hand Sanitizer 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

Ethyl alcohol 75% V/V

Purpose

Antimicrobial.

Uses

Hand Sanitizer to help reduce bacteria on skin that potentially can cause disease.

For use when soap and water are not available.

Warnings

Flammable. Keep away from fire or flame.
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

If swallowed, get medical help or contact a poison control center right away.

Directions

Spray enough product on hands to cover all surfaces. Rub hands together briskly until dry.

Children under 6 years of age should be supervised when using Puroma hand sanitizer

Inactive ingredients

Water,Isopropyl Alcohol ,Glycerin, Isopropyl Myristate, Alpha.- Tocopherol Acetate , Caprylyl Glycol, Aloe Vera Leaf, Propylene Glycol, Coco-Caprylate , PEG-7 Glyceryl Cocoate, Glyceryl Oleate

Other information

Store below 110°F (43°C).
May discolor certain fabrics or surfaces.

Product label

INGREDIENTS AND APPEARANCE

PUROMA HAND SANITIZER FRAGRANCE FREE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80948-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCO-CAPRYLATE (UNII: 4828G836N6)
GLYCERYL OLEATE (UNII: 4PC054V79P)
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80948-010-01	6 in 1 PACKAGE	03/12/2021	03/12/2021
1		30 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 80948-010-02	8 in 1 PACKAGE	03/12/2021	03/12/2021
2		30 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 80948-010-03	12 in 1 PACKAGE	03/12/2021	03/12/2021
3		30 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 80948-010-04	24 in 1 PACKAGE	03/12/2021	03/12/2021
4		30 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC: 80948-010-05	48 in 1 PACKAGE	03/12/2021	03/12/2021
5		30 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC: 80948-010-06	6 in 1 PACKAGE	03/12/2021	03/12/2021
6		50 mL in 1 PACKAGE; Type 0: Not a Combination Product
7	NDC: 80948-010-07	8 in 1 PACKAGE	03/12/2021	03/12/2021
7		50 mL in 1 PACKAGE; Type 0: Not a Combination Product
8	NDC: 80948-010-08	12 in 1 PACKAGE	03/12/2021	03/12/2021
8		50 mL in 1 PACKAGE; Type 0: Not a Combination Product
9	NDC: 80948-010-09	24 in 1 PACKAGE	03/12/2021	03/12/2021
9		50 mL in 1 PACKAGE; Type 0: Not a Combination Product
10	NDC: 80948-010-10	48 in 1 PACKAGE	03/12/2021	03/12/2021
10		50 mL in 1 PACKAGE; Type 0: Not a Combination Product
11	NDC: 80948-010-11	6 in 1 PACKAGE	03/12/2021	03/12/2021
11		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
12	NDC: 80948-010-12	8 in 1 PACKAGE	03/12/2021	03/12/2021
12		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
13	NDC: 80948-010-13	12 in 1 PACKAGE	03/12/2021	03/12/2021
13		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
14	NDC: 80948-010-14	24 in 1 PACKAGE	03/12/2021	03/12/2021
14		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
15	NDC: 80948-010-15	48 in 1 PACKAGE	03/12/2021	03/12/2021
15		60 mL in 1 PACKAGE; Type 0: Not a Combination Product
16	NDC: 80948-010-16	6 in 1 PACKAGE	03/12/2021	03/12/2021
16		100 mL in 1 PACKAGE; Type 0: Not a Combination Product
17	NDC: 80948-010-17	8 in 1 PACKAGE	03/12/2021	03/12/2021
17		100 mL in 1 PACKAGE; Type 0: Not a Combination Product
18	NDC: 80948-010-18	12 in 1 PACKAGE	03/12/2021	03/12/2021
18		100 mL in 1 PACKAGE; Type 0: Not a Combination Product
19	NDC: 80948-010-19	24 in 1 PACKAGE	03/12/2021	03/12/2021
19		100 mL in 1 PACKAGE; Type 0: Not a Combination Product
20	NDC: 80948-010-20	48 in 1 PACKAGE	03/12/2021	03/12/2021
20		100 mL in 1 PACKAGE; Type 0: Not a Combination Product
21	NDC: 80948-010-21	4 in 1 PACKAGE	03/12/2021	03/12/2021
21		200 mL in 1 PACKAGE; Type 0: Not a Combination Product
22	NDC: 80948-010-22	6 in 1 PACKAGE	03/12/2021	03/12/2021
22		200 mL in 1 PACKAGE; Type 0: Not a Combination Product
23	NDC: 80948-010-23	8 in 1 PACKAGE	03/12/2021	03/12/2021
23		200 mL in 1 PACKAGE; Type 0: Not a Combination Product
24	NDC: 80948-010-24	12 in 1 PACKAGE	03/12/2021	03/12/2021
24		200 mL in 1 PACKAGE; Type 0: Not a Combination Product
25	NDC: 80948-010-25	24 in 1 PACKAGE	03/12/2021	03/12/2021
25		200 mL in 1 PACKAGE; Type 0: Not a Combination Product
26	NDC: 80948-010-26	48 in 1 PACKAGE	03/12/2021	03/12/2021
26		200 mL in 1 PACKAGE; Type 0: Not a Combination Product
27	NDC: 80948-010-27	4 in 1 PACKAGE	03/12/2021	03/12/2021
27		250 mL in 1 PACKAGE; Type 0: Not a Combination Product
28	NDC: 80948-010-28	6 in 1 PACKAGE	03/12/2021	03/12/2021
28		250 mL in 1 PACKAGE; Type 0: Not a Combination Product
29	NDC: 80948-010-29	8 in 1 PACKAGE	03/12/2021	03/12/2021
29		250 mL in 1 PACKAGE; Type 0: Not a Combination Product
30	NDC: 80948-010-30	12 in 1 PACKAGE	03/12/2021	03/12/2021
30		250 mL in 1 PACKAGE; Type 0: Not a Combination Product
31	NDC: 80948-010-31	24 in 1 PACKAGE	03/12/2021	03/12/2021
31		250 mL in 1 PACKAGE; Type 0: Not a Combination Product
32	NDC: 80948-010-32	48 in 1 PACKAGE	03/12/2021	03/12/2021
32		250 mL in 1 PACKAGE; Type 0: Not a Combination Product
33	NDC: 80948-010-33	2 in 1 PACKAGE	03/12/2021
33		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
34	NDC: 80948-010-34	4 in 1 PACKAGE	03/12/2021
34		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
35	NDC: 80948-010-35	6 in 1 PACKAGE	03/12/2021
35		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
36	NDC: 80948-010-36	8 in 1 PACKAGE	03/12/2021
36		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
37	NDC: 80948-010-37	12 in 1 PACKAGE	03/12/2021
37		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
38	NDC: 80948-010-38	24 in 1 PACKAGE	03/12/2021
38		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
39	NDC: 80948-010-39	48 in 1 PACKAGE	03/12/2021
39		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
40	NDC: 80948-010-40	2 in 1 PACKAGE	03/12/2021
40		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
41	NDC: 80948-010-41	4 in 1 PACKAGE	03/12/2021
41		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
42	NDC: 80948-010-42	6 in 1 PACKAGE	03/12/2021
42		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
43	NDC: 80948-010-43	5000 mL in 1 CAN; Type 0: Not a Combination Product	03/12/2021
44	NDC: 80948-010-44	50000 mL in 1 CAN; Type 0: Not a Combination Product	03/12/2021
45	NDC: 80948-010-45	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/12/2021
46	NDC: 80948-010-46	6 in 1 PACKAGE	10/19/2021
46		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
47	NDC: 80948-010-47	8 in 1 PACKAGE	10/19/2021
47		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
48	NDC: 80948-010-48	12 in 1 PACKAGE	10/19/2021
48		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
49	NDC: 80948-010-49	24 in 1 PACKAGE	10/19/2021
49		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
50	NDC: 80948-010-50	48 in 1 PACKAGE	10/19/2021
50		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
51	NDC: 80948-010-51	6 in 1 PACKAGE	10/19/2021
51		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
52	NDC: 80948-010-52	8 in 1 PACKAGE	10/19/2021
52		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
53	NDC: 80948-010-53	12 in 1 PACKAGE	10/19/2021
53		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
54	NDC: 80948-010-54	24 in 1 PACKAGE	10/19/2021
54		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
55	NDC: 80948-010-55	48 in 1 PACKAGE	10/19/2021
55		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
56	NDC: 80948-010-56	6 in 1 PACKAGE	10/19/2021
56		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
57	NDC: 80948-010-57	8 in 1 PACKAGE	10/19/2021
57		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
58	NDC: 80948-010-58	12 in 1 PACKAGE	10/19/2021
58		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
59	NDC: 80948-010-59	24 in 1 PACKAGE	10/19/2021
59		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
60	NDC: 80948-010-60	48 in 1 PACKAGE	10/19/2021
60		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
61	NDC: 80948-010-61	6 in 1 PACKAGE	10/19/2021
61		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
62	NDC: 80948-010-62	8 in 1 PACKAGE	10/19/2021
62		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
63	NDC: 80948-010-63	12 in 1 PACKAGE	10/19/2021
63		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
64	NDC: 80948-010-64	24 in 1 PACKAGE	10/19/2021
64		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
65	NDC: 80948-010-65	48 in 1 PACKAGE	10/19/2021
65		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
66	NDC: 80948-010-66	4 in 1 PACKAGE	10/19/2021
66		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
67	NDC: 80948-010-67	6 in 1 PACKAGE	10/19/2021
67		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
68	NDC: 80948-010-68	8 in 1 PACKAGE	10/19/2021
68		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
69	NDC: 80948-010-69	12 in 1 PACKAGE	10/19/2021
69		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
70	NDC: 80948-010-70	24 in 1 PACKAGE	10/19/2021
70		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
71	NDC: 80948-010-71	48 in 1 PACKAGE	10/19/2021
71		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
72	NDC: 80948-010-72	4 in 1 PACKAGE	10/19/2021
72		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
73	NDC: 80948-010-73	6 in 1 PACKAGE	10/19/2021
73		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
74	NDC: 80948-010-74	8 in 1 PACKAGE	10/19/2021
74		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
75	NDC: 80948-010-75	12 in 1 PACKAGE	10/19/2021
75		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
76	NDC: 80948-010-76	24 in 1 PACKAGE	10/19/2021
76		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
77	NDC: 80948-010-77	48 in 1 PACKAGE	10/19/2021
77		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
78	NDC: 80948-010-78	2 in 1 PACKAGE	10/19/2021
78		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
79	NDC: 80948-010-79	4 in 1 PACKAGE	10/19/2021
79		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
80	NDC: 80948-010-80	6 in 1 PACKAGE	10/19/2021
80		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
81	NDC: 80948-010-81	8 in 1 PACKAGE	10/19/2021
81		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
82	NDC: 80948-010-82	12 in 1 PACKAGE	10/19/2021
82		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
83	NDC: 80948-010-83	24 in 1 PACKAGE	10/19/2021
83		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
84	NDC: 80948-010-84	48 in 1 PACKAGE	10/19/2021
84		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
85	NDC: 80948-010-85	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
86	NDC: 80948-010-86	200 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
87	NDC: 80948-010-87	100 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	03/12/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Establishment
Name	Address	ID/FEI	Business Operations
ZENITH MICRO CONTROL		915625571	manufacture(80948-010)