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 70% V/V

Purpose

Antimicrobial

Uses

Hand Sanitizer to help reduce bacteria on skin.

Warnings

For external use only. 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

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

Other information

Store below 110°F (430°C)
May discolor certain fabrics or surfaces

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PUROMA HAND SANITIZER FRAGRANCE FREE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80948-009
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)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
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: 80948-009-01	6 in 1 PACKAGE	03/11/2021	03/11/2021
1		30 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 80948-009-02	12 in 1 PACKAGE	03/11/2021	03/11/2021
2		30 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 80948-009-03	24 in 1 PACKAGE	03/11/2021	03/11/2021
3		30 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 80948-009-04	48 in 1 PACKAGE	03/11/2021	03/11/2021
4		30 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC: 80948-009-05	6 in 1 PACKAGE	03/11/2021
5		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 80948-009-06	12 in 1 PACKAGE	03/11/2021
6		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC: 80948-009-07	24 in 1 PACKAGE	03/11/2021
7		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC: 80948-009-08	48 in 1 PACKAGE	03/11/2021
8		60 mL in 1 BOTTLE; Type 0: Not a Combination Product
9	NDC: 80948-009-09	4 in 1 PACKAGE	03/11/2021
9		89 mL in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 80948-009-10	6 in 1 PACKAGE	03/11/2021
10		89 mL in 1 BOTTLE; Type 0: Not a Combination Product
11	NDC: 80948-009-11	12 in 1 PACKAGE	03/11/2021
11		89 mL in 1 BOTTLE; Type 0: Not a Combination Product
12	NDC: 80948-009-12	24 in 1 PACKAGE	03/11/2021
12		89 mL in 1 BOTTLE; Type 0: Not a Combination Product
13	NDC: 80948-009-13	48 in 1 PACKAGE	03/11/2021
13		89 mL in 1 BOTTLE; Type 0: Not a Combination Product
14	NDC: 80948-009-14	4 in 1 PACKAGE	03/11/2021
14		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
15	NDC: 80948-009-15	6 in 1 PACKAGE	03/11/2021
15		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
16	NDC: 80948-009-16	12 in 1 PACKAGE	03/11/2021
16		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
17	NDC: 80948-009-17	24 in 1 PACKAGE	03/11/2021
17		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
18	NDC: 80948-009-18	48 in 1 PACKAGE	03/11/2021
18		178 mL in 1 BOTTLE; Type 0: Not a Combination Product
19	NDC: 80948-009-19	4 in 1 PACKAGE	03/11/2021
19		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
20	NDC: 80948-009-20	6 in 1 PACKAGE	03/11/2021
20		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
21	NDC: 80948-009-21	12 in 1 PACKAGE	03/11/2021
21		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
22	NDC: 80948-009-22	24 in 1 PACKAGE	03/11/2021
22		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
23	NDC: 80948-009-23	48 in 1 PACKAGE	03/11/2021
23		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
24	NDC: 80948-009-24	2 in 1 PACKAGE	03/11/2021
24		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
25	NDC: 80948-009-25	4 in 1 PACKAGE	03/11/2021
25		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
26	NDC: 80948-009-26	6 in 1 PACKAGE	03/11/2021
26		326 mL in 1 BOTTLE; Type 0: Not a Combination Product
27	NDC: 80948-009-27	2 in 1 PACKAGE	03/11/2021
27		488 mL in 1 BOTTLE; Type 0: Not a Combination Product
28	NDC: 80948-009-28	2 in 1 PACKAGE	03/11/2021
28		947 mL in 1 BOTTLE; Type 0: Not a Combination Product
29	NDC: 80948-009-29	5000 mL in 1 CAN; Type 0: Not a Combination Product	03/11/2021
30	NDC: 80948-009-30	50000 mL in 1 CAN; Type 0: Not a Combination Product	03/11/2021
31	NDC: 80948-009-31	200000 mL in 1 DRUM; Type 0: Not a Combination Product	03/11/2021
32	NDC: 80948-009-32	6 in 1 PACKAGE	10/19/2021
32		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
33	NDC: 80948-009-33	12 in 1 PACKAGE	10/19/2021
33		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
34	NDC: 80948-009-34	24 in 1 PACKAGE	10/19/2021
34		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
35	NDC: 80948-009-35	48 in 1 PACKAGE	10/19/2021
35		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
36	NDC: 80948-009-36	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
37	NDC: 80948-009-37	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
38	NDC: 80948-009-38	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
39	NDC: 80948-009-39	488 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/19/2021
40	NDC: 80948-009-40	947 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	03/11/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Establishment
Name	Address	ID/FEI	Business Operations
ZENITH MICRO CONTROL		915625571	manufacture(80948-009)