SOPURE 80% ETHANOL SANITIZING WIPES- ethanol cloth

SOPURE 80% Ethanol Sanitizing wipes by

Drug Labeling and Warnings

SOPURE 80% Ethanol Sanitizing wipes by is a Otc medication manufactured, distributed, or labeled by EnviroServe Chemicals & Cleaners Ltd., EnviroServe Chemicals & Cleaners Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Ethanol 80%

Purpose

Medicated Skin Cleanser Kills harmful bacteria/germs

Uses

Hand Sanitizing wipes Kills harmful bacteria/germs.

Warnings

For external use only.

Flammable keep away from fire or flame, heat, spark, electrical

Avoid contact with eyes. In case of contact, rinse eyes thoroughly with water.
If irritation develops, consult a doctor. Keep out of reach of children.
Do not use on children / infants less than 2 years of age (unless directed by a doctor or physician).
If swallowed, call a poison control center or get medical help right away.

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not get in eyes

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Use as need on basis. Wipe your hands to help prevent spread of bacteria.

Other information

• keep Packet tightly closed and stored at room temperature
• hold away from face when opening

Inactive ingredient

Water, glycerin, hydrogen peroxide, alpha tocopherol acetate

Questions or comments?

nfo@sopureproductsinc.com

Package Labeling:

SoPure 80 Wipes

SoPure 100 Wipes

SoPure 120 wipes

SoPure 160 Wipes

INGREDIENTS AND APPEARANCE

SOPURE 80% ETHANOL SANITIZING WIPES 
ethanol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80773-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80773-003-00	80 in 1 PACKET	06/16/2023
1		4.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2	NDC: 80773-003-01	100 in 1 PACKET	06/16/2023
2		4.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3	NDC: 80773-003-02	120 in 1 PACKET	06/16/2023
3		4.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4	NDC: 80773-003-03	160 in 1 PACKET	06/16/2023
4		4.5 mL in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	06/16/2023

Labeler - EnviroServe Chemicals & Cleaners Ltd. (243690711)

Registrant - EnviroServe Chemicals & Cleaners Ltd. (243690711)

Establishment
Name	Address	ID/FEI	Business Operations
EnviroServe Chemicals & Cleaners Ltd		243690711	manufacture(80773-003)