FDA.reportPublic FDA data

SOPURE

Manufacturer
EnviroServe Chemicals & Cleaners Ltd
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:43:52

Label at a glance#

ProductSOPURE
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Denatured Ethanol 80%v/v

Purpose

OTC - PURPOSE SECTION

Medicated Skin Cleanser Kills harmful bacteria/germs

Warnings

WARNINGS SECTION

  • 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

INDICATIONS & USAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use on children / infants less than 2 years of age (unless directed by a doctor or physician.)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

SoPure 20 ml

Front LabelFront Label

Back LabelBack Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80773-001SOPURE (DENATURED ETHANOL) LIQUID [ENVIROSERVE CHEMICALS & CLEANERS LTD]8Legacy NDC20250101_a3fd9f59-a6ee-4eef-a3e1-63fd534a6142.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80773-00180773-001-01, 80773-001-02, 80773-001-03, 80773-001-04, 80773-001-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYSORBATE 207T1F30V5YHIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
37b9a75d-14f4-866d-e063-6294a90ab4e7a3fd9f59-a6ee-4eef-a3e1-63fd534a61422025-06-16WarningsExact identifier
spl set id: a3fd9f59-a6ee-4eef-a3e1-63fd534a6142

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.