BIOSILK- benzalkonium chloride soap 
Farouk Systems, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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BioSilk Foam Hand Antibacterial Soap

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

BSHS06 Biosilk Antibacterial Hand Soap Label 6oz

Active Ingredient

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

BSHS06 Biosilk Antibacterial Hand Soap Label 6oz

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.

BSHS06 Biosilk Antibacterial Hand Soap Label 6oz

Purpose

Uses

For handwashing to decrease bacteria on the skjin

Recommended for repeated use

BSHS06 Biosilk Antibacterial Hand Soap Label 6oz

Indications & Usage


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

Directions
•Wethandsandforearms
•Applyenoughproducttoadequatelycovertheenliresurfacesofthehandsandforearms
•Scrublhoroughlyforatleast30seconds(incluefingernailsandculicles)
•Rinse

BSHS06 Biosilk Antibacterial Hand Soap Label 6oz

Warnings


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

BSHS06 Biosilk Antibacterial Hand Soap Label 6oz

Storage and Handling


Other information
•Storeinadrycoolplacel:lelow104"f

BSHS06 Biosilk Antibacterial Hand Soap Label 6oz

Dosage & Administration

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

Directions
•Wethandsandforearms
•Applyenoughproducttoadequatelycovertheenliresurfacesofthehandsandforearms
•Scrublhoroughlyforatleast30seconds(incluefingernailsandculicles)
•Rinse

BSHS06 Biosilk Antibacterial Hand Soap Label 6oz

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)

BSHS06 Biosilk Antibacterial Hand Soap Label 6oz

BIOSILK 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73740-4040
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73740-4040-6163 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2020
2NDC:73740-4040-1340 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2020
3NDC:73740-4040-5739 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/31/2020
Labeler - Farouk Systems, Inc. (137598132)
Registrant - Faoruk Systems, Inc. (137598132)
Establishment
NameAddressID/FEIBusiness Operations
Farouk Systems, Inc.137598132manufacture(73740-4040)

Revised: 3/2020
Document Id: a22d11ea-e391-d9a4-e053-2a95a90acd3a
Set id: a22d11ea-e390-d9a4-e053-2a95a90acd3a
Version: 1
Effective Time: 20200331
 
Farouk Systems, Inc.