NDC 73740-6060 Biosilk

Benzalkonium Chloride

NDC Product Code 73740-6060

NDC 73740-6060-2

Package Description: 354.88 g in 1 BOTTLE, PUMP

NDC 73740-6060-4

Package Description: 975.93 g in 1 BOTTLE, PUMP

NDC Product Information

Biosilk with NDC 73740-6060 is a a human over the counter drug product labeled by Farouk Systems, Inc.. The generic name of Biosilk is benzalkonium chloride. The product's dosage form is soap and is administered via topical form.

Labeler Name: Farouk Systems, Inc.

Dosage Form: Soap - Any compound of one or more fatty acids, or their equivalents, with an alkali; soap is detergent and is much employed in liniments, enemas, and in making pills. It is also a mild aperient, antacid and antiseptic.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Biosilk Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZALKONIUM .13 g/100g
  • BENZALKONIUM .13 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • COCAMIDE (UNII: 3YXD33R71G)
  • COUMARIN (UNII: A4VZ22K1WT)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • SILK, ACID HYDROLYZED (1000 MW) (UNII: 8549W658QV)
  • PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ALCOHOL (UNII: 3K9958V90M)
  • BUTYLPHENYL METHYLPROPIONAL, (+)- (UNII: WP1PPC4R9G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
  • WATER (UNII: 059QF0KO0R)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Cutaneous - Administration to the skin.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Cutaneous - Administration to the skin.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Farouk Systems, Inc.
Labeler Code: 73740
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-13-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Biosilk Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Active ingredient Purpose

Benzalkonium Chloride 0.13%................................Antimicrobial

Inactive Ingredients

Inactive ingredients: Aqua/Water/Eau, Cocamidopropyl

Betaine, Cocamide DIPA, Glycerin, Cocamidopropyl

Hydroxysultaine, Decyl Glucoside, Aloe Barbadensis Leaf

Juice, Lavandula Angustifolia (Lavender) Oil, Hydrolyzed Silk,

Caprylyl Glycol, PEG-150 Pentaerythrityl Tetrastearate,

Hexylene Glycol, Pentylene Glycol, PEG-6 Caprylic/Capric

Glycerides, Cetrimonium Chloride, Ethylhexylglycerin,

Propanediol, Alcohol Denat., Citric Acid, Fragrance (Parfum),

Benzyl Benzoate, Butylphenyl Methylpropional, Coumarin

Keep Out O Freach Of Children

Keep out of reach of children. In case of accidental ingestion,

get medical help or contact a Poison Control Center immediately.

Uses

Use[s] for handwashing to decrease bacteria on the skin

recommended for repeated use

Use[s] for handwashing to decrease bacteria on the skin

recommended for repeated use

Stop Use And Ask A Doctor

Stop use and ask a doctor if irritation and redness develop

Directions

Directions

wet hands and forearms apply enough product to adequately cover the entire surface of hands and forearms

scrub thoroughly for at least 30 seconds (including fingernails and cuticles rinse

Warnings

Warnings

For external use only.

When using this product

do not use in or near 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.

* Please review the disclaimer below.