Label: BIOSILK- benzalkonium chloride soap

  • NDC Code(s): 73740-4040-1, 73740-4040-5, 73740-4040-6
  • Packager: Farouk Systems, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated March 31, 2020

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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)