Drug Facts

Active ingredient

Isopropyl Alcohol 75% v/v.

Purpose

Antibacterial

Uses

Hand Sanitizer to help reduce bacteria on skin.

Warnings

• For external use only. Flammable. Keep away from fire or flame
• 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 doctorif 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

• 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 ingredients

Water

Product label

PUROMA IPA HAND SANITIZER WIPE
isopropyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80948-019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:80948-019-01	10 in 1 PACKAGE	04/27/2021	04/27/2021
1		66 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:80948-019-02	20 in 1 PACKAGE	04/27/2021	04/27/2021
2		132 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:80948-019-03	40 in 1 PACKAGE	04/27/2021	04/27/2021
3		264 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:80948-019-04	80 in 1 PACKAGE	04/27/2021	04/27/2021
4		528 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:80948-019-05	120 in 1 PACKAGE	04/27/2021	04/27/2021
5		792 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC:80948-019-06	50 in 1 CANISTER	04/27/2021	04/27/2021
6		350 mL in 1 CANISTER; Type 0: Not a Combination Product
7	NDC:80948-019-07	80 in 1 CANISTER	04/27/2021	04/27/2021
7		560 mL in 1 PACKAGE; Type 0: Not a Combination Product
8	NDC:80948-019-08	100 in 1 CANISTER	04/27/2021	04/27/2021
8		700 mL in 1 CANISTER; Type 0: Not a Combination Product
9	NDC:80948-019-09	120 in 1 CANISTER	04/27/2021	04/27/2021
9		840 mL in 1 CANISTER; Type 0: Not a Combination Product
10	NDC:80948-019-10	10 in 1 POUCH	10/19/2021
10		66 mL in 1 POUCH; Type 0: Not a Combination Product
11	NDC:80948-019-11	20 in 1 POUCH	10/19/2021
11		132 mL in 1 POUCH; Type 0: Not a Combination Product
12	NDC:80948-019-12	40 in 1 POUCH	10/19/2021
12		264 mL in 1 POUCH; Type 0: Not a Combination Product
13	NDC:80948-019-13	80 in 1 CANISTER	10/19/2021
13		528 mL in 1 CANISTER; Type 0: Not a Combination Product
14	NDC:80948-019-14	120 in 1 CANISTER	10/19/2021
14		792 mL in 1 CANISTER; Type 0: Not a Combination Product
15	NDC:80948-019-15	50 in 1 CANISTER	10/19/2021
15		330 mL in 1 CANISTER; Type 0: Not a Combination Product
16	NDC:80948-019-16	100 in 1 CANISTER	10/19/2021
16		660 mL in 1 CANISTER; Type 0: Not a Combination Product
17	NDC:80948-019-17	1 in 1 PACKET	10/19/2021
17		6.6 mL in 1 PACKET; Type 0: Not a Combination Product
18	NDC:80948-019-18	25 in 1 BOX	10/19/2021
18		165 mL in 1 PACKET; 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	04/27/2021

Labeler - ZENITH MICRO CONTROL (915625571)

Name	Address	ID/FEI	Business Operations
Establishment
ZENITH MICRO CONTROL		915625571	manufacture(80948-019)