BIOSILK- benzalkonium chloride soap

Biosilk by

Drug Labeling and Warnings

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

Drug Details [pdf]

Inactive ingredients

Inactive infedients: Aqu,JWater/Eau, Sodium C14-16 Olefin Sulfonate,
Cocamidopropy Betaine, Glycenn, Melaleuca Alternifolia gea Tre Leaf Oil, Aloe Bart>adensis Leaf
Juice, Hydrolyzed Silk, Phenoxyehtanol, aprylyl lycol, Disodium, Laureth
Sulfosuccinate,Cetrimonium Chloride, Potassium Sorbate, TetrasodiumEDTA, Hexylene Glycol, Alcohol
Denat., Citric Acid, Sodium Chloride, Fragrance (Partum), Limonene, Cltral ID: 80-BSHSO

Active Ingredient

Active ingredient Purpose
Benzalkonium Chloride0.1% .................................................. ........ ....... ....
Antibacterial

Keep out of reach of Children

Keep out of reach of children.
Incase of accidental ingestion, seek medical attention or contact Poison Control Center
immediately.

Purpose

Uses

For handwashing to decrease bacteria on the skjin

Recommended for repeated use

Indications & Usage

Use[s[
For handwashing to decrease bacteria on the skin
Recommended for repeated use

Directions
Wethandsandforearms
Applyenoughproducttoadequatelycovertheenliresurfacesofthehandsandforearms
Scrublhoroughlyforatleast30seconds(incluefingernailsandculicles)
Rinse

Warnings

Warnings
ForBIIBrnaluseonly.
Whan using this product
Donotuseinorneareyes
Discontinueuseifirritationandrednessdevelop
Keepoutolreacholchildren.
lncaseofaccidentalingestion,seekmedicalattentionorcontactPoisonContmlCenter immediately.

Storage and Handling

Other information
Storeinadrycoolplacel:lelow104"f

Dosage & Administration

Active ingredient Purpose
BenzalkoniumChloride0.1%
.....................................................................Antibacterial

Directions
Wethandsandforearms
Applyenoughproducttoadequatelycovertheenliresurfacesofthehandsandforearms
Scrublhoroughlyforatleast30seconds(incluefingernailsandculicles)
Rinse

Principal Display Panel

BIOSILK®
HEALTH+CARE
ANTIBACTERIAL
HAND
SOAP
WITH
ALOE VERA &_TEA TREE

FOR SILKY, SOFT HANDS

92% Natural

MADE IN THE USA
11.5 FL OZ (340 ml)

INGREDIENTS AND APPEARANCE

BIOSILK 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73740-4040
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	0.011 g  in 100 g
WATER (UNII: 059QF0KO0R)	88.5419 g  in 100 g
ANHYDROMETHYLENECITRIC ACID (UNII: 99197U4E9K)	0.001 g  in 100 g
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.1755 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	1.5 g  in 100 g
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.0915 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X)	0.001 g  in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	0.5 g  in 100 g
ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4)	0.084 g  in 100 g
SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV)	0.0011 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.4 g  in 100 g
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.4 g  in 100 g
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)	0.2 g  in 100 g
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	0.1 g  in 100 g
HEXYLENE GLYCOL (UNII: KEH0A3F75J)	0.05 g  in 100 g
CITRAL (UNII: T7EU0O9VPP)	0.033 g  in 100 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	3.5 g  in 100 g
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)	4 g  in 100 g
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)	0.3 g  in 100 g
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)	0.01 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73740-4040-6	163 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/31/2020
2	NDC: 73740-4040-1	340 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/31/2020
3	NDC: 73740-4040-5	739 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/31/2020

Labeler - Farouk Systems, Inc. (137598132)

Registrant - Faoruk Systems, Inc. (137598132)

Establishment
Name	Address	ID/FEI	Business Operations
Farouk Systems, Inc.		137598132	manufacture(73740-4040)