FDA.reportPublic FDA data

Hand Sanitizer Spray 1 Gallon

Manufacturer
Assured Bio Labs, LLC
Effective date
2020-10-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:09:27

Label at a glance#

ProductAssured Bio Infection Protection Hand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

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.

Storage and handling

Do not store above 115°F May discolor some fabrics. May damage wood finishes or plastics.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Hand sanitizer to decrease bacteria on the skin that could cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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

STORAGE AND HANDLING SECTION

  • Do not store above 115°F
  • May discolor some fabrics.
  • May damage wood finishes or plastics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Fragrance, glycerin, isopropyl alcohol, purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 mL NDC: 79334-002-02 3785 mL NDC: 79334-002-023785 mL NDC: 79334-002-02

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79334-002-022022-09-27C16284748780-1c7ccaba7-1812-fd44-e053-dadaa90aa01bHand Sanitizer Spray 1 Gallon
79334-002-022021-07-23C16284748780-1c7ccaba7-1812-fd44-e053-dadaa90aa01bHand Sanitizer Spray 1 Gallon

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79334-00279334-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
ISOPROPYL ALCOHOLND2M416302IACT

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
e8a86ae8-319a-5949-e053-2a95a90a8e6fb2bd1bb3-faf7-5694-e053-2995a90a25272022-09-14WarningsExact identifier
spl set id: b2bd1bb3-faf7-5694-e053-2995a90a2527

Reported adverse events (FAERS/openFDA)#

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