PUROMA Instant Foaming Hand Sanitizer without Fragrance by ZENITH MICRO CONTROL

PUROMA Instant Foaming Hand Sanitizer without Fragrance by

Drug Labeling and Warnings

PUROMA Instant Foaming Hand Sanitizer without Fragrance by is a Otc medication manufactured, distributed, or labeled by ZENITH MICRO CONTROL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE- alcohol liquid 
ZENITH MICRO CONTROL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Alcohol 70% V/V

Purpose

Antimicrobial.

Uses

Hand Sanitizer to help reduce bacteria on skin.

Recommended for repeated use.

Warnings

Flammable. Keep away from fire or flame.
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

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 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, PEG-12 Dimethicone (300 CST)

Other information

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

Product label

PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80948-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 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)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80948-008-01	4 in 1 PACKAGE	03/10/2021
1		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 80948-008-02	6 in 1 PACKAGE	03/10/2021	04/12/2021
2		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 80948-008-03	12 in 1 PACKAGE	03/10/2021	04/12/2021
3		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 80948-008-04	24 in 1 PACKAGE	03/10/2021	04/12/2021
4		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC: 80948-008-05	48 in 1 PACKAGE	03/10/2021	04/12/2021
5		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 80948-008-06	4 in 1 PACKAGE	03/10/2021	04/12/2021
6		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 80948-008-07	6 in 1 PACKAGE	03/10/2021	04/12/2021
7		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 80948-008-08	12 in 1 PACKAGE	03/10/2021	04/12/2021
8		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 80948-008-09	24 in 1 PACKAGE	03/10/2021	04/12/2021
9		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 80948-008-10	48 in 1 PACKAGE	03/10/2021	04/12/2021
10		70 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 80948-008-11	4 in 1 PACKAGE	03/10/2021	04/12/2021
11		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 80948-008-12	6 in 1 PACKAGE	03/10/2021	04/12/2021
12		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 80948-008-13	12 in 1 PACKAGE	03/10/2021	04/12/2021
13		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 80948-008-14	24 in 1 PACKAGE	03/10/2021	04/12/2021
14		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 80948-008-15	48 in 1 PACKAGE	03/10/2021	04/12/2021
15		80 mL in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 80948-008-16	4 in 1 PACKAGE	03/10/2021	04/12/2021
16		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 80948-008-17	6 in 1 PACKAGE	03/10/2021	04/12/2021
17		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC: 80948-008-18	12 in 1 PACKAGE	03/10/2021	04/12/2021
18		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
19	NDC: 80948-008-19	24 in 1 PACKAGE	03/10/2021	04/12/2021
19		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
20	NDC: 80948-008-20	48 in 1 PACKAGE	03/10/2021	04/12/2021
20		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
21	NDC: 80948-008-21	4 in 1 PACKAGE	03/10/2021	04/12/2021
21		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
22	NDC: 80948-008-22	6 in 1 PACKAGE	03/10/2021	04/12/2021
22		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
23	NDC: 80948-008-23	12 in 1 PACKAGE	03/10/2021	04/12/2021
23		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
24	NDC: 80948-008-24	24 in 1 PACKAGE	03/10/2021	04/12/2021
24		150 mL in 1 BOTTLE; Type 0: Not a Combination Product
25	NDC: 80948-008-25	4 in 1 PACKAGE	03/10/2021	04/12/2021
25		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
26	NDC: 80948-008-26	6 in 1 PACKAGE	03/10/2021	04/12/2021
26		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
27	NDC: 80948-008-27	12 in 1 PACKAGE	03/10/2021	04/12/2021
27		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
28	NDC: 80948-008-28	24 in 1 PACKAGE	03/10/2021	04/12/2021
28		200 mL in 1 BOTTLE; Type 0: Not a Combination Product
29	NDC: 80948-008-29	4 in 1 PACKAGE	03/10/2021	04/12/2021
29		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
30	NDC: 80948-008-30	6 in 1 PACKAGE	03/10/2021	04/12/2021
30		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
31	NDC: 80948-008-31	12 in 1 PACKAGE	03/10/2021	04/12/2021
31		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
32	NDC: 80948-008-32	24 in 1 PACKAGE	03/10/2021	04/12/2021
32		220 mL in 1 BOTTLE; Type 0: Not a Combination Product
33	NDC: 80948-008-33	2 in 1 PACKAGE	03/10/2021	04/12/2021
33		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
34	NDC: 80948-008-34	4 in 1 PACKAGE	03/10/2021	04/12/2021
34		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
35	NDC: 80948-008-35	6 in 1 PACKAGE	03/10/2021	04/12/2021
35		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
36	NDC: 80948-008-36	12 in 1 PACKAGE	03/10/2021	04/12/2021
36		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
37	NDC: 80948-008-37	24 in 1 PACKAGE	03/10/2021	04/12/2021
37		250 mL in 1 BOTTLE; Type 0: Not a Combination Product
38	NDC: 80948-008-38	2 in 1 PACKAGE	03/10/2021	04/12/2021
38		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
39	NDC: 80948-008-39	4 in 1 PACKAGE	03/10/2021	04/12/2021
39		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
40	NDC: 80948-008-40	6 in 1 PACKAGE	03/10/2021	04/12/2021
40		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
41	NDC: 80948-008-41	12 in 1 PACKAGE	03/10/2021	04/12/2021
41		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
42	NDC: 80948-008-42	24 in 1 PACKAGE	03/10/2021	04/12/2021
42		300 mL in 1 PACKAGE; Type 0: Not a Combination Product
43	NDC: 80948-008-43	2 in 1 PACKAGE	03/10/2021	04/12/2021
43		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
44	NDC: 80948-008-44	4 in 1 PACKAGE	03/10/2021	04/12/2021
44		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
45	NDC: 80948-008-45	6 in 1 PACKAGE	03/10/2021	04/12/2021
45		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
46	NDC: 80948-008-46	12 in 1 PACKAGE	03/10/2021	04/12/2021
46		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
47	NDC: 80948-008-47	24 in 1 PACKAGE	03/10/2021	04/12/2021
47		350 mL in 1 BOTTLE; Type 0: Not a Combination Product
48	NDC: 80948-008-48	5000 mL in 1 CAN; Type 0: Not a Combination Product	03/10/2021	04/12/2021
49	NDC: 80948-008-49	50000 mL in 1 CAN; Type 0: Not a Combination Product	03/10/2021	04/12/2021
50	NDC: 80948-008-50	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/10/2021	04/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/10/2021	04/12/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Establishment
Name	Address	ID/FEI	Business Operations
ZENITH MICRO CONTROL		915625571	manufacture(80948-008)

Revised: 4/2021

Document Id: bfcde97b-3c28-4f8b-e053-2a95a90a88fa

34390-5

Set id: 1548edb7-5e3c-46ac-96ee-86d9f3979122

Version: 2

Effective Time: 20210412