Label: BIOSILK- biosilk hand and body lotion lotion

  • 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 September 8, 2020

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

  • Active Ingredient

    Active ingredient Purpose
    Benzalkonium Chloride 0.13%................................Antimicrobial

    lotion

  • Inactive ingredients

    Inactive ingredients: Aqua/Water/Eau, Dimethicone,
    Cetyl Alcohol, C15-19 Alkane, Propanediol, Glycerin, Cetearyl
    Alcohol, Glyceryl Stearate SE, Ceteareth-20, Caprylyl Glycol,
    Aloe Barbadensis Leaf Juice, Lavandula Angustifolia
    (Lavender) Oil, Hydrolyzed Silk, Dimethiconol, Hexylene
    Glycol, Butyrospermum Parkii (Shea) Butter, Pentylene
    Glycol, Ethylhexylglycerin, Dicetyldimonium Chloride, Alcohol
    Denat., Sodium Hydroxide, Fragrance (Parfum), Benzyl
    Benzoate, Butylphenyl Methylpropional, Coumarin, Linalool

     lotion

  • Keep out of reach of children

    Keep out of reach of children. In case of accidental ingestion,
    get medical help or contact a Poison Control Center immediately.

      lotion

  • Purpose

    Use[s] to help reduce bacteria on the skin
    recommended for routine use

       lotion

  • Uses

    Use[s] to help reduce bacteria on the skin
    recommended for routine use

        lotion

  • Warnings

    Warnings
    For external use only.
    When using this product
    avoid contact with 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. In case of accidental ingestion,
    get medical help or contact a Poison Control Center immediately.

         lotion

  • Directions

    Directions
    apply a small amount to palm and rub hands together thoroughly

            lotion

  • Primary Display Panel

    Biosilk

    Health + Care

    Antibacterial

    Hand & Body

    Lotion

    with aloe vera, lavender & silk

    95% Natural Paraben Free

    Kills 99.9% of Germs

    FDA Registration #

    NDC 73740-5050-1

           lotion

  • INGREDIENTS AND APPEARANCE
    BIOSILK 
    biosilk hand and body lotion lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73740-5050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM (UNII: 7N6JUD5X6Y) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV) 0.01 g  in 100 g
    PENTYLENE GLYCOL (UNII: 50C1307PZG) 0.3 g  in 100 g
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.2 g  in 100 g
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.00065 g  in 100 g
    LINALOOL, (+/-)- (UNII: D81QY6I88E) 0.012 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    LAVENDER OIL (UNII: ZBP1YXW0H8) 0.05 g  in 100 g
    BENZYL BENZOATE (UNII: N863NB338G) 0.2 g  in 100 g
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) 0.03 g  in 100 g
    COUMARIN (UNII: A4VZ22K1WT) 0.016 g  in 100 g
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 1.9 g  in 100 g
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) 1.4 g  in 100 g
    C15-19 ALKANE (UNII: CI87N1IM01) 3 g  in 100 g
    WATER (UNII: 059QF0KO0R) 76.25635 g  in 100 g
    DIMETHICONE (UNII: 92RU3N3Y1O) 4.72 g  in 100 g
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S) 0.48 g  in 100 g
    DICETYLDIMONIUM CHLORIDE (UNII: 6F4SX2007N) 0.14 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) 0.011 g  in 100 g
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.142 g  in 100 g
    CETYL ALCOHOL (UNII: 936JST6JCN) 3.8 g  in 100 g
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 1.4 g  in 100 g
    CAPRYLYL GLYCOL (UNII: 00YIU5438U) 1 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.001 g  in 100 g
    HEXYLENE GLYCOL (UNII: KEH0A3F75J) 0.4 g  in 100 g
    SHEA BUTTER (UNII: K49155WL9Y) 0.3 g  in 100 g
    PROPANEDIOL (UNII: 5965N8W85T) 2.1 g  in 100 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73740-5050-1354.88 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/13/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/13/2020
    Labeler - Farouk Systems, Inc. (137598132)
    Registrant - Farouk Systems, Inc. (137598132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Farouk Systems, Inc.137598132manufacture(73740-5050)