FDA.reportPublic FDA data

BioSilk Hand Sanitizer

Manufacturer
Farouk Systems, Inc.
Effective date
2020-09-09
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-05-31 23:28:49

Label at a glance#

ProductBioSilk Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Storage and handling

Other information Do not store at temperatures above 105°F

Label contents#

Full prescribing information#

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Active ingredient Purpose
Ethyl Alcohol 77% v/v Antimicrobial

Use for hand-washing to decrease bacteria on
the skin, only when water is not available.

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
Aloe Barbadensis Leaf
Extract*, Aqua/Water/Eau,
Glycerin, Propanediol,
Acrylates/C10-30 Alkyl
Acrylate Crosspolymer,
Aminomethyl Propanol,
Fragrance (Parfum), Citral,
Limonene, Linalool
ID: 80-CHIOGAVHS
*organically grown aloe vera,
certification pending

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose
Ethyl Alcohol 77% v/v Antimicrobial

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

Route, Methos and Frequency of Administration

ROUTE, METHOD AND FREQUENCY OF ADMINISTRATION

Use for hand-washing to decrease bacteria on
the skin, only when water is not available.

Directions
wet hands
thoroughly with
product and allow
to dry without
wiping
for children
under 6, use only
under adult
supervision

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

Warnings and Precautions

WARNINGS AND PRECAUTIONS SECTION

Warnings
Flammable, keep away from fire and flames.
For external use only.
When using this product
do not get into eyes
if contact occurs, rinse eyes
thoroughly with water
Stop use and ask a doctor if:
irritation and redness
develop
Keep out of reach of
children. If swallowed,
get medical help or
contact a Poison
Control Center right
away

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

Storage and Handling

STORAGE AND HANDLING SECTION

Other information
Do not store at
temperatures above
105°F

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

Indications & Usage

INDICATIONS & USAGE SECTION

Use for hand-washing to decrease bacteria on
the skin, only when water is not available.

Directions
wet hands
thoroughly with
product and allow
to dry without
wiping
for children
under 6, use only
under adult
supervision

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

Warnings

WARNINGS SECTION

Warnings
Flammable, keep away from fire and flames.
For external use only.
When using this product
do not get into eyes
if contact occurs, rinse eyes
thoroughly with water
Stop use and ask a doctor if:
irritation and redness
develop
Keep out of reach of
children. If swallowed,
get medical help or
contact a Poison
Control Center right
away

BioSilk 2ozBioSilk 2oz

OTC - Keep out of reach of Children

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

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

Purpose

OTC - PURPOSE SECTION

Use for hand-washing to decrease bacteria on
the skin, only when water is not available.

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BioSilk

Moisturizing Hand Sanitizer'

With Soothing Aloe Vera

92% Natural

KILLS 99.99% OF GERMS

MADE IN THE USA

2.2 FL OZ (65 mL)

Biosilk Hand Sanitizer Labels_PRESS-2_2ozBiosilk Hand Sanitizer Labels_PRESS-2_2oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1788839ethanol 77 % Topical GelPSN18
1788839ethanol 0.77 ML/ML Topical GelSCD18
1788839ethanol 77 % Topical GelSY18

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73740-2020-02022-01-28C16284748780-1d6a99b39-fbd9-a426-e053-dadaa90af4c2BioSilk Hand Sanitizer
73740-2020-12022-01-28C16284748780-1d6a99b39-fbd9-a426-e053-dadaa90af4c2BioSilk Hand Sanitizer
73740-2020-22022-01-28C16284748780-1d6a99b39-fbd9-a426-e053-dadaa90af4c2BioSilk Hand Sanitizer
73740-2020-32022-01-28C16284748780-1d6a99b39-fbd9-a426-e053-dadaa90af4c2BioSilk Hand Sanitizer
73740-2020-42022-01-28C16284748780-1d6a99b39-fbd9-a426-e053-dadaa90af4c2BioSilk Hand Sanitizer
73740-2020-52022-01-28C16284748780-1d6a99b39-fbd9-a426-e053-dadaa90af4c2BioSilk Hand Sanitizer
73740-2020-62022-01-28C16284748780-1d6a99b39-fbd9-a426-e053-dadaa90af4c2BioSilk Hand Sanitizer
73740-2020-72022-01-28C16284748780-1d6a99b39-fbd9-a426-e053-dadaa90af4c2BioSilk Hand Sanitizer
73740-2020-92022-01-28C16284748780-1d6a99b39-fbd9-a426-e053-dadaa90af4c2BioSilk Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73740-2020-0BioSilk Hand Sanitizer208198 g in 1 DRUMGEL20819818
73740-2020-1BioSilk Hand Sanitizer354 g in 1 BOTTLEGEL35418
73740-2020-2BioSilk Hand Sanitizer65 g in 1 BOTTLEGEL6518
73740-2020-3BioSilk Hand Sanitizer59 g in 1 BOTTLEGEL5918
73740-2020-4BioSilk Hand Sanitizer1041000 g in 1 CONTAINERGEL104100018
73740-2020-5BioSilk Hand Sanitizer159 g in 1 BOTTLEGEL15918
73740-2020-6BioSilk Hand Sanitizer177 g in 1 BOTTLEGEL17718
73740-2020-7BioSilk Hand Sanitizer355 g in 1 BOTTLEGEL35518
73740-2020-9BioSilk Hand Sanitizer3785 g in 1 JUGGEL378518

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73740-2020BIOSILK HAND SANITIZER (ALCOHOL (ETHYL ALCOHOL)) GEL [FAROUK SYSTEMS, INC.]18Legacy NDC, 9 package rows20200910_a14aa569-5304-3480-e053-2995a90af0d1.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73740-202073740-2020-2, 73740-2020-5, 73740-2020-1, 73740-2020-0, 73740-2020-3, 73740-2020-9, 73740-2020-4, 73740-2020-7, 73740-2020-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRALT7EU0O9VPPIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
ALCOHOL3K9958V90MACTIB
ALOE VERA LEAFZY81Z83H0XIACT
PROPANEDIOL5965N8W85TIACT
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
LINALOOL, (+)-F4VNO44C09IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
LIMONENE, (+)-GFD7C86Q1WIACT

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
aee89905-1f3c-e987-e053-2a95a90a2f31a14aa569-5304-3480-e053-2995a90af0d12020-09-09WarningsExact identifier
spl id: aee89905-1f3c-e987-e053-2a95a90a2f31
spl set id: a14aa569-5304-3480-e053-2995a90af0d1

Reported adverse events (FAERS/openFDA)#

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