FDA.reportPublic FDA data

BioPure

Manufacturer
QUEST USA CORP
Effective date
2020-06-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:24:10

Label at a glance#

ProductBioPure
Active ingredientALCOHOL
Label structure10 sections

Dosage and administration

Apply to hands, allow to air dry without wiping. Discard wipe in trash receptacle after use. Do not flush.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria that potentially cause disease.
  • For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable, Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age.
  • on open skin wounds.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. ears. and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation or rash occurs. These may be signs or serious condition.

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

  • Apply to hands, allow to air dry without wiping.
  • Discard wipe in trash receptacle after use.
  • Do not flush.

Other Information

SPL UNCLASSIFIED SECTION

  • Store in a cool, dry place, betwen 15°-30°C (59°F-86°F).
  • Avoid freezing and excessive heat above 40°C (104°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water USP

Questions?

OTC - QUESTIONS SECTION

call 718-975-2586

Package Labeling:78691-001-40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Package Labeling:78691-001-50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle2Bottle2

Package Labeling:78691-001-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78691-00178691-001-40, 78691-001-50, 78691-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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
c78fd8ed-6ce4-c84f-e053-2a95a90ac398a9008c4e-9b99-241b-e053-2a95a90a1c272021-07-20WarningsExact identifier
spl set id: a9008c4e-9b99-241b-e053-2a95a90a1c27

Reported adverse events (FAERS/openFDA)#

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