PUROMA ALCOHOL 75% HAND SANITIZER WIPE- alcohol cloth

PUROMA Alcohol 75% Hand Sanitizer Wipe by

Drug Labeling and Warnings

PUROMA Alcohol 75% Hand Sanitizer Wipe 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

Antibacterial

Uses

Hand Sanitizer to help reduce bacteria on skin.

Warnings 

For external use only.
When using this productdo not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor ifirritation 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 thoroughly with product and allow to dry.
Discard wipe in trash receptacle after use. Do not flush
Children under 6 years of age should be supervised when using Puroma Hand Sanitizer wipe.

Other information 

Store below 104°F (40°C).
May discolor certain fabrics or surfaces

Inactive ingredient

Water

Product label

INGREDIENTS AND APPEARANCE

PUROMA ALCOHOL 75% HAND SANITIZER WIPE 
alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80948-013
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80948-013-01	10 in 1 PACKAGE	04/23/2021	04/23/2021
1		66 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC: 80948-013-02	20 in 1 PACKAGE	04/23/2021	04/23/2021
2		132 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC: 80948-013-03	40 in 1 PACKAGE	04/23/2021	04/23/2021
3		264 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC: 80948-013-04	80 in 1 PACKAGE	04/23/2021	04/23/2021
4		528 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC: 80948-013-05	120 in 1 PACKAGE	04/23/2021
5		792 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC: 80948-013-06	50 in 1 CANISTER	04/23/2021	04/23/2021
6		350 mL in 1 PACKAGE; Type 0: Not a Combination Product
7	NDC: 80948-013-07	80 in 1 CANISTER	04/23/2021	04/23/2021
7		560 mL in 1 PACKAGE; Type 0: Not a Combination Product
8	NDC: 80948-013-08	100 in 1 CANISTER	04/23/2021	04/23/2021
8		700 mL in 1 CANISTER; Type 0: Not a Combination Product
9	NDC: 80948-013-09	120 in 1 CANISTER	04/23/2021	04/23/2021
9		840 mL in 1 CANISTER; Type 0: Not a Combination Product
10	NDC: 80948-013-10	10 in 1 POUCH	10/19/2021
10		66 mL in 1 POUCH; Type 0: Not a Combination Product
11	NDC: 80948-013-11	20 in 1 POUCH	10/19/2021
11		132 mL in 1 POUCH; Type 0: Not a Combination Product
12	NDC: 80948-013-12	40 in 1 POUCH	10/19/2021
12		264 mL in 1 POUCH; Type 0: Not a Combination Product
13	NDC: 80948-013-13	80 in 1 POUCH	10/19/2021
13		528 mL in 1 POUCH; Type 0: Not a Combination Product
14	NDC: 80948-013-14	120 in 1 POUCH	10/19/2021
14		792 mL in 1 POUCH; Type 0: Not a Combination Product
15	NDC: 80948-013-15	50 in 1 CANISTER	10/19/2021
15		330 mL in 1 CANISTER; Type 0: Not a Combination Product
16	NDC: 80948-013-16	80 in 1 CANISTER	10/19/2021
16		528 mL in 1 CANISTER; Type 0: Not a Combination Product
17	NDC: 80948-013-17	100 in 1 CANISTER	10/19/2021
17		660 mL in 1 CANISTER; Type 0: Not a Combination Product
18	NDC: 80948-013-18	120 in 1 CANISTER	10/19/2021
18		792 mL in 1 CANISTER; Type 0: Not a Combination Product
19	NDC: 80948-013-20	1 in 1 PACKET	10/19/2021
19		6.6 mL in 1 PACKET; Type 0: Not a Combination Product
20	NDC: 80948-013-21	25 in 1 BOX	10/19/2021
20		165 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	04/23/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Establishment
Name	Address	ID/FEI	Business Operations
ZENITH MICRO CONTROL		915625571	manufacture(80948-013)