FDA.reportPublic FDA data

HAND SANITIZER

Manufacturer
BioBarrier360 LLC
Effective date
2020-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:41

Label at a glance#

ProductHAND SANITIZER
Active ingredientALCOHOL
Label structure10 sections

Indications and uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. 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 ingredients

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can 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

  • On 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 thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Stop use and seek a doctor if 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

OTHER SAFETY INFORMATION

  • Store between 15-30C (59-86F).
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Carbomer, Glycerin, Triethanolamine, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

Questions?

OTC - QUESTIONS SECTION

call (877) 458-1315

Company Information

SPL UNCLASSIFIED SECTION

Distributed By:

BioBarrier360 LLC

Austin, TX 78758

www.BioBarrier360.com

Made in Guatemala

Product Packaging - 500 ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOBARRIER360

Hand Sanitizer

with moisturizing ingredients

Alcohol 70%

16.9 fl oz 500 ml

www.BioBarrier360.com

hand sanitizerhand sanitizer

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78426-001-012022-01-28C16284748780-1d6a99b39-a854-a426-e053-dadaa90af4c2BioBarrier360 Hand Sanitizer
78426-001-022022-01-28C16284748780-1d6a99b39-a854-a426-e053-dadaa90af4c2BioBarrier360 Hand Sanitizer
78426-001-032022-01-28C16284748780-1d6a99b39-a854-a426-e053-dadaa90af4c2BioBarrier360 Hand Sanitizer
78426-001-042022-01-28C16284748780-1d6a99b39-a854-a426-e053-dadaa90af4c2BioBarrier360 Hand Sanitizer
78426-001-052022-01-28C16284748780-1d6a99b39-a854-a426-e053-dadaa90af4c2BioBarrier360 Hand Sanitizer
78426-001-062022-01-28C16284748780-1d6a99b39-a854-a426-e053-dadaa90af4c2BioBarrier360 Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78426-001-01HAND SANITIZER59 mL in 1 BOTTLE, PLASTICGEL591
78426-001-02HAND SANITIZER118 mL in 1 BOTTLE, PLASTICGEL1181
78426-001-03HAND SANITIZER236 mL in 1 BOTTLE, PLASTICGEL2361
78426-001-04HAND SANITIZER500 mL in 1 BOTTLE, PLASTICGEL5001
78426-001-05HAND SANITIZER1000 mL in 1 BOTTLE, PLASTICGEL10001
78426-001-06HAND SANITIZER3785 mL in 1 BOTTLE, PLASTICGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78426-001HAND SANITIZER (ALCOHOL) GEL [BIOBARRIER360 LLC]1Legacy NDC, 6 package rows20200602_a710a11a-b62f-4765-e053-2995a90ac825.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78426-00178426-001-01, 78426-001-02, 78426-001-03, 78426-001-04, 78426-001-05, 78426-001-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT

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
a710ad38-61ee-9321-e053-2995a90a32bca710a11a-b62f-4765-e053-2995a90ac8252020-06-01WarningsExact identifier
spl id: a710ad38-61ee-9321-e053-2995a90a32bc
spl set id: a710a11a-b62f-4765-e053-2995a90ac825

Reported adverse events (FAERS/openFDA)#

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