SOPURE- denatured ethanol liquid

SOPURE by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Denatured Ethanol 80%v/v

Purpose

Medicated Skin Cleanser Kills harmful bacteria/germs

Warnings

• 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). 
• Ifswallowed, call a poison control center or get medical help right away. 
• Keep away from open flame and sources of heat.

Uses

Hand Sanitizer / Medicated Skin Cleanser Kills harmful bacteria/germs.

Directions

• Spray product on dry hands, rub for 30 seconds. 
• This product should be sued as part of the daily cleansing routine.

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.)

Inactive Ingredients

Water, natural glycerol / glycerin, emollients (contains tocopherol, vitamin E, may contain aloe babadensis, fragrances, DE&; F color additives.)

Product Label

INGREDIENTS AND APPEARANCE

SOPURE 
denatured ethanol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80773-001
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)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80773-001-01	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2020
2	NDC: 80773-001-02	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2020
3	NDC: 80773-001-03	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2020
4	NDC: 80773-001-04	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/07/2020

Labeler - EnviroServe Chemicals & Cleaners Ltd (243690711)