BIOSILK HAND SANITIZER (alcohol- ethyl alcohol gel

BioSilk Hand Sanitizer by

Drug Labeling and Warnings

BioSilk Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Farouk Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage & Administration

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.

Inactive Ingredients

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

Active Ingredients

Active ingredient Purpose
Ethyl Alcohol 77% v/v Antimicrobial

Route, Methos 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

Warnings and Precautions

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

Storage and Handling

Other information
Do not store at
temperatures above
105°F

Indications & Usage

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

Warnings

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

OTC - Keep out of reach of Children

Keep out of reach of
children. If swallowed,
get medical help or
contact a Poison
Control Center right
away

Purpose

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

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)

INGREDIENTS AND APPEARANCE

BIOSILK HAND SANITIZER 
alcohol (ethyl alcohol) gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73740-2020
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	77 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CITRAL (UNII: T7EU0O9VPP)	0.0275 g  in 100 g
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)	0.095 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	28.5 g  in 100 g
PROPANEDIOL (UNII: 5965N8W85T)	2 g  in 100 g
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.0715 g  in 100 g
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)	0.4 g  in 100 g
LINALOOL, (+)- (UNII: F4VNO44C09)	0.00475 g  in 100 g
WATER (UNII: 059QF0KO0R)	6.255 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	2 g  in 100 g
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.14625 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73740-2020-2	65 g in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020
2	NDC: 73740-2020-5	159 g in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020
3	NDC: 73740-2020-1	354 g in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020
4	NDC: 73740-2020-0	208198 g in 1 DRUM; Type 0: Not a Combination Product	04/06/2020
5	NDC: 73740-2020-3	59 g in 1 BOTTLE; Type 0: Not a Combination Product	04/09/2020
6	NDC: 73740-2020-9	3785 g in 1 JUG; Type 0: Not a Combination Product	04/09/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/18/2020

Labeler - Farouk Systems, Inc. (137598132)

Registrant - Farouk Systems, Inc. (137598132)

Establishment
Name	Address	ID/FEI	Business Operations
Farouk Systems, Inc.		137598132	manufacture(73740-2020)