FDA.reportPublic FDA data

BioTech Gel Hand Sanitizer

Manufacturer
BioTech Industries
Effective date
2020-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:14:05

Label at a glance#

ProductBioTech Gel Hand Sanitizer
Active ingredientALCOHOL
Label structure8 sections

Dosage and administration

Wet hands thoroughly with products and allow to dry without wiping. For children under six years, use only under adult supervision. Not recommended for infants.

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

For handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from heat or flame

When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours.

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

Wet hands thoroughly with products and allow to dry without wiping.

For children under six years, use only under adult supervision.

Not recommended for infants.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerol, hydrogen peroxide, sterile distilled water or boiled cold water, scent, rapid gel

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77791-001-012021-07-23C16284748780-1c7ccaba7-298b-fd44-e053-dadaa90aa01bb2415360-1403-49e0-b650-1cef61cf08c7
77791-001-022021-07-23C16284748780-1c7ccaba7-298b-fd44-e053-dadaa90aa01bb2415360-1403-49e0-b650-1cef61cf08c7
77791-001-032021-07-23C16284748780-1c7ccaba7-298b-fd44-e053-dadaa90aa01bb2415360-1403-49e0-b650-1cef61cf08c7
77791-001-042021-07-23C16284748780-1c7ccaba7-298b-fd44-e053-dadaa90aa01bb2415360-1403-49e0-b650-1cef61cf08c7
77791-001-052021-07-23C16284748780-1c7ccaba7-298b-fd44-e053-dadaa90aa01bb2415360-1403-49e0-b650-1cef61cf08c7
77791-001-062021-07-23C16284748780-1c7ccaba7-298b-fd44-e053-dadaa90aa01bb2415360-1403-49e0-b650-1cef61cf08c7
77791-001-072021-07-23C16284748780-1c7ccaba7-298b-fd44-e053-dadaa90aa01bb2415360-1403-49e0-b650-1cef61cf08c7
77791-001-082021-07-23C16284748780-1c7ccaba7-298b-fd44-e053-dadaa90aa01bb2415360-1403-49e0-b650-1cef61cf08c7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77791-001-01BioTech Gel Hand Sanitizer59 mL in 1 BOTTLE, PLASTICGEL591
77791-001-02BioTech Gel Hand Sanitizer118 mL in 1 BOTTLE, PLASTICGEL1181
77791-001-03BioTech Gel Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361
77791-001-04BioTech Gel Hand Sanitizer473 mL in 1 BOTTLE, PLASTICGEL4731
77791-001-05BioTech Gel Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICGEL37851
77791-001-06BioTech Gel Hand Sanitizer18927 mL in 1 BOTTLE, PLASTICGEL189271
77791-001-07BioTech Gel Hand Sanitizer208198 mL in 1 DRUMGEL2081981
77791-001-08BioTech Gel Hand Sanitizer946353 mL in 1 CONTAINERGEL9463531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77791-001BIOTECH GEL HAND SANITIZER (ALCOHOL) GEL [BIOTECH INDUSTRIES]1Legacy NDC, 8 package rows20200521_b2415360-1403-49e0-b650-1cef61cf08c7.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77791-00177791-001-01, 77791-001-02, 77791-001-03, 77791-001-04, 77791-001-05, 77791-001-06, 77791-001-07, 77791-001-08

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
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
e64b4581-85ed-4054-9703-06499662e722b2415360-1403-49e0-b650-1cef61cf08c72020-05-16WarningsExact identifier
spl id: e64b4581-85ed-4054-9703-06499662e722
spl set id: b2415360-1403-49e0-b650-1cef61cf08c7

Reported adverse events (FAERS/openFDA)#

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