FDA.reportPublic FDA data

SOPURE 80% Ethanol Sanitizing wipes

Manufacturer
EnviroServe Chemicals & Cleaners Ltd. | EnviroServe Chemicals & Cleaners Ltd
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:44:02

Label at a glance#

ProductSOPURE 80% Ethanol Sanitizing wipes
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Hand Sanitizing wipes Kills harmful bacteria/germs.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethanol 80%

Purpose

OTC - PURPOSE SECTION

Medicated Skin Cleanser Kills harmful bacteria/germs

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizing wipes Kills harmful bacteria/germs.

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product

OTC - WHEN USING SECTION

  • do not get in eyes

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

Water, glycerin, hydrogen peroxide, alpha tocopherol acetate

Questions or comments?

OTC - QUESTIONS SECTION

nfo@sopureproductsinc.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SoPure 80 Wipes

LabelLabel

SoPure 100 Wipes

LabelLabel

SoPure 120 wipes

LabelLabel

SoPure 160 Wipes

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80773-003SOPURE 80% ETHANOL SANITIZING WIPES (ETHANOL) CLOTH [ENVIROSERVE CHEMICALS & CLEANERS LTD.]3Unmatched20250101_fe410150-69e2-7348-e053-6394a90a1c47.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
80773-00380773-003-00, 80773-003-01, 80773-003-02, 80773-003-03

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
ALCOHOL3K9958V90MACTIB
HYDROGEN PEROXIDEBBX060AN9VIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXIACT

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
37b9aee0-f7bd-b154-e063-6394a90aca1bfe410150-69e2-7348-e053-6394a90a1c472025-06-16WarningsExact identifier
spl set id: fe410150-69e2-7348-e053-6394a90a1c47

Reported adverse events (FAERS/openFDA)#

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