BIOSILK HAND SANITIZER- alcohol (ethyl alcohol) gel 
Farouk Systems, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BioSilk Hand Sanitizer

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.

Biosilk Hand Sanitizer Labels_PRESS-2_2oz

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

Biosilk Hand Sanitizer Labels_PRESS-2_2oz

Active Ingredients

Active ingredient Purpose
Ethyl Alcohol 77% v/v Antimicrobial

Biosilk Hand Sanitizer Labels_PRESS-2_2oz

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

Biosilk Hand Sanitizer Labels_PRESS-2_2oz

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

Biosilk Hand Sanitizer Labels_PRESS-2_2oz

Storage and Handling

Other information
Do not store at
temperatures above
105°F

Biosilk Hand Sanitizer Labels_PRESS-2_2oz

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

Biosilk Hand Sanitizer Labels_PRESS-2_2oz

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

BioSilk 2oz

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

Biosilk Hand Sanitizer Labels_PRESS-2_2oz

Purpose

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

Biosilk Hand Sanitizer Labels_PRESS-2_2oz

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_2oz

BIOSILK HAND SANITIZER 
alcohol (ethyl alcohol) gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73740-2020
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73740-2020-265 g in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
2NDC:73740-2020-5159 g in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
3NDC:73740-2020-1354 g in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
4NDC:73740-2020-0208198 g in 1 DRUM; Type 0: Not a Combination Product04/06/2020
5NDC:73740-2020-359 g in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
6NDC:73740-2020-93785 g in 1 JUG; Type 0: Not a Combination Product04/09/2020
7NDC:73740-2020-41041000 g in 1 CONTAINER; Type 0: Not a Combination Product04/30/2020
8NDC:73740-2020-7355 g in 1 BOTTLE; Type 0: Not a Combination Product04/02/2020
9NDC:73740-2020-6177 g in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/18/2020
Labeler - Farouk Systems, Inc. (137598132)
Registrant - Farouk Systems, Inc. (137598132)
Establishment
NameAddressID/FEIBusiness Operations
Farouk Systems, Inc.137598132manufacture(73740-2020)

Revised: 9/2020
Document Id: aee89905-1f3c-e987-e053-2a95a90a2f31
Set id: a14aa569-5304-3480-e053-2995a90af0d1
Version: 18
Effective Time: 20200909
 
Farouk Systems, Inc.