Biopure personal protective

Manufacturer
QUEST USA CORP.
Effective date
2022-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:45:07

Label at a glance#

ProductBiopure personal protective
Active ingredientALCOHOL
Label structure17 sections

Indications and uses

Hand sanitizer to help reduce bacteria. For use when soap and water are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Hand sanitizer to help reduce bacteria.
  • 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 ears, eyes 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 of a 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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

SPL UNCLASSIFIED SECTION

  • Store between 59°-86°F (15°-30°C)
  • Do not store above 104°F (40°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

Carbopol 940, Glycerine, Propylene Glycol, Triethanolamine, Water (Aqua)

Questions?

OTC - QUESTIONS SECTION

Call 718-975-2586

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • Hand antiseptic to help reduce bacteria.
  • 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 ears, eyes 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 of a 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.
  • Supervise children under 6 years of age when using this product.

Other information

SPL UNCLASSIFIED SECTION

  • Store between 59°-86°F (15°-30°C)
  • Do not store above 104°F (40°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water USP

Questions?

OTC - QUESTIONS SECTION

Call 718-975-2586

Package Labeling:Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKit

Package Labeling:78691-006-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle5Bottle5

Package Labeling:78691-007-00

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle6Bottle6

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78691-00578691-005-00
78691-00678691-006-00
78691-00778691-007-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
f305d354-1be6-6f76-e053-2995a90ac091ad2af46c-725d-2490-e053-2a95a90a50432023-01-24WarningsExact identifier
spl set id: ad2af46c-725d-2490-e053-2a95a90a5043

Reported adverse events (FAERS/openFDA)#

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