Label: BIOSILK HAND SANITIZER (alcohol- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 9, 2020

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

  • Dosage & Administration

    Active ingredient Purpose
    Ethyl Alcohol 77% v/v Antimicrobial

    Use for hand-washing to decrease bacteria on
    the skin, only when water is not available.

            Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • Inactive Ingredients

    Inactive ingredients
    Aloe Barbadensis Leaf
    Extract*, Aqua/Water/Eau,
    Glycerin, Propanediol,
    Acrylates/C10-30 Alkyl
    Acrylate Crosspolymer,
    Aminomethyl Propanol,
    Fragrance (Parfum), Citral,
    Limonene, Linalool
    ID: 80-CHIOGAVHS
    *organically grown aloe vera,
    certification pending

       Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • Active Ingredients

    Active ingredient Purpose
    Ethyl Alcohol 77% v/v Antimicrobial

             Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • Route, Methos and Frequency of Administration

    Use for hand-washing to decrease bacteria on
    the skin, only when water is not available.

    Directions
    wet hands
    thoroughly with
    product and allow
    to dry without
    wiping
    for children
    under 6, use only
    under adult
    supervision

        Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • Warnings and Precautions

    Warnings
    Flammable, keep away from fire and flames.
    For external use only.
    When using this product
    do not get into 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. If swallowed,
    get medical help or
    contact a Poison
    Control Center right
    away

          Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • Storage and Handling

    Other information
    Do not store at
    temperatures above
    105°F

         Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • Indications & Usage

    Use for hand-washing to decrease bacteria on
    the skin, only when water is not available.

    Directions
    wet hands
    thoroughly with
    product and allow
    to dry without
    wiping
    for children
    under 6, use only
    under adult
    supervision

    Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • Warnings

    Warnings
    Flammable, keep away from fire and flames.
    For external use only.
    When using this product
    do not get into 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. If swallowed,
    get medical help or
    contact a Poison
    Control Center right
    away

    BioSilk 2oz

  • OTC - Keep out of reach of Children

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

      Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • Purpose

    Use for hand-washing to decrease bacteria on
    the skin, only when water is not available.

     Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • Principal Display Panel

    BioSilk

    Moisturizing Hand Sanitizer'

    With Soothing Aloe Vera

    92% Natural

    KILLS 99.99% OF GERMS

    MADE IN THE USA

    2.2 FL OZ (65 mL)

           Biosilk Hand Sanitizer Labels_PRESS-2_2oz

  • INGREDIENTS AND APPEARANCE
    BIOSILK HAND SANITIZER 
    alcohol (ethyl alcohol) gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73740-2020
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRAL (UNII: T7EU0O9VPP) 0.0275 g  in 100 g
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) 0.095 g  in 100 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 28.5 g  in 100 g
    PROPANEDIOL (UNII: 5965N8W85T) 2 g  in 100 g
    FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.0715 g  in 100 g
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) 0.4 g  in 100 g
    LINALOOL, (+)- (UNII: F4VNO44C09) 0.00475 g  in 100 g
    WATER (UNII: 059QF0KO0R) 6.255 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 2 g  in 100 g
    LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.14625 g  in 100 g
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73740-2020-265 g in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
    2NDC:73740-2020-5159 g in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
    3NDC:73740-2020-1354 g in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
    4NDC:73740-2020-0208198 g in 1 DRUM; Type 0: Not a Combination Product04/06/2020
    5NDC:73740-2020-359 g in 1 BOTTLE; Type 0: Not a Combination Product04/09/2020
    6NDC:73740-2020-93785 g in 1 JUG; Type 0: Not a Combination Product04/09/2020
    7NDC:73740-2020-41041000 g in 1 CONTAINER; Type 0: Not a Combination Product04/30/2020
    8NDC:73740-2020-7355 g in 1 BOTTLE; Type 0: Not a Combination Product04/02/2020
    9NDC:73740-2020-6177 g in 1 BOTTLE; Type 0: Not a Combination Product03/18/2020
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/18/2020
    Labeler - Farouk Systems, Inc. (137598132)
    Registrant - Farouk Systems, Inc. (137598132)
    Establishment
    NameAddressID/FEIBusiness Operations
    Farouk Systems, Inc.137598132manufacture(73740-2020)