FDA.reportPublic FDA data

BiOSS Hand Sanitizer

Manufacturer
Bioss Inc.
Effective date
2020-05-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:13:41

Label at a glance#

ProductBiOSS Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Indications and uses

Effective in killing bacteria (harmful) to provide an antiseptic cleaning. For personal hand hygiene to prevent the spread of bacteria.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 75%

Purpose

OTC - PURPOSE SECTION

Antiseptic skin cleanser

USES

INDICATIONS & USAGE SECTION

Effective in killing bacteria (harmful) to provide an antiseptic cleaning. For personal hand hygiene to prevent the spread of bacteria.

WARNINGS

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat and flame.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes. In case of contact, immediately flush eyes with water.

Stop use and consult a health care practitioner if

OTC - STOP USE SECTION

irritation or redness develops.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Do not use on children/infants under 2 years old (except on the advice of a doctor).

DIRECTION

DOSAGE & ADMINISTRATION SECTION

For occasional use for personal household use. Rub well for at least 30 seconds. Let dry.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Store at 20°C (68° to 77°F) cool place.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Acrylates/c10-30, Alkyl Acrylate Crosspolymer, Triethanolamine, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Lemon oil. 

QUESTIONS?

OTC - QUESTIONS SECTION

1-866-795-8481

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77134-000-002022-01-28C16284748780-1d6a99b39-8be4-a426-e053-dadaa90af4c2BiOSS Hand Sanitizer Lemon Scent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77134-000-00BiOSS Hand Sanitizer500 mL in 1 BOTTLEGEL5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77134-000BIOSS HAND SANITIZER (ALCOHOL) GEL [BIOSS INC.]2Legacy NDC, 1 package rows20200520_a0dcd3f3-115c-44a5-a85c-60030cd9804f.zip

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
77134-00077134-000-00

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
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
TROLAMINE9O3K93S3TKIACT
BERGAMOT OIL39W1PKE3JIIACT
LEMON OILI9GRO824LLIACT
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
a60458a5-9ddc-1fe6-e053-2a95a90a2749a0dcd3f3-115c-44a5-a85c-60030cd9804f2020-05-19WarningsExact identifier
spl id: a60458a5-9ddc-1fe6-e053-2a95a90a2749
spl set id: a0dcd3f3-115c-44a5-a85c-60030cd9804f

Reported adverse events (FAERS/openFDA)#

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