BIOSILK (alcohol- ethyl alcohol spray

BioSilk by

Drug Labeling and Warnings

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

Drug Details [pdf]

Dosage & Administration

Directions
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years od age when using this product to avoid swallowing.

Inactive Ingredients

Inactive ingredients: Glycerin, Hydrogen Peroxide, Purified Water
USP ID:80-BSHNS

Active Ingredient

Active ingredient[s] Purpose
Alcohol 80% v/v.......................................……………...................................Antiseptic

Keep out of reach of children

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

Purpose

Active ingredient[s] Purpose
Alcohol 80% v/v.......................................……………...................................Antiseptic

Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when
soap and water are not available.

Storage and Handling

Other information
Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Warnings

Warnings
For external use only. Flammable. Keep away from heat or flame.

Do not use
in children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with
eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious
condition.

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

Indications & Usage

Active ingredient[s] Purpose
Alcohol 80% v/v.......................................……………...................................Antiseptic

Use[s]
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when
soap and water are not available.

Principal Display Panel

BioSilk

MOISTURIZING
HAND
2
SANITIZER
SPRAY
WITH
ALCOHOL & PEROXIDE
ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION
HAND SANITIZER NON-STERILE SOLUTION
KILLS 99.99% OF GERMS
92%
MADE IN THE USA
2 FL OZ (59 mL)

INGREDIENTS AND APPEARANCE

BIOSILK 
alcohol (ethyl alcohol) spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73740-3030
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	18.425 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	1.45 g  in 100 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73740-3030-2	59 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/27/2020
2	NDC: 73740-3030-8	237 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/27/2020

Labeler - Farouk Systems, Inc. (137598132)

Registrant - Farouk Systems, Inc. (137598132)

Establishment
Name	Address	ID/FEI	Business Operations
Farouk Systems, Inc.		137598132	manufacture(73740-3030)