NDC 73740-7070 Biosilk

Benzalkonium Chloride

NDC Product Code 73740-7070

NDC 73740-7070-1

Package Description: 354.88 g in 1 BOTTLE

NDC Product Information

Biosilk with NDC 73740-7070 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 shampoo and is administered via topical form.

Labeler Name: Farouk Systems, Inc.

Dosage Form: Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.

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 CHLORIDE .1 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.

  • PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
  • POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
  • PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
  • COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • ALCOHOL (UNII: 3K9958V90M)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • AMINO ACIDS, SILK (UNII: V0L00EX1IA)
  • CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • GLYCOL DISTEARATE (UNII: 13W7MDN21W)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • COUMARIN (UNII: A4VZ22K1WT)

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

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: 09-30-2020 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 Label Images

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

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.

Directions

Directions

apply to wet hair and

lather rinse thoroughly

can be used daily

Use

Use as a shampoo to help reduce bacteria

Active Ingredient

Active ingredient Purpose

Benzalkonium Chloride 0.10% Antimicrobial

Stop Use And Ask A Doctor

Stop use and ask a doctor if

irritation and redness develop

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.

When Using This Product

When using this product

do not use in or near eyes

if contact occurs, rinse eyes thoroughly

with water

Purpose

Antimicrobial

Inactive Ingredients

Aqua/Water/Eau,

Cocamidopropyl

Betaine,

Cocamidopropyl

Hydroxysultaine,

Glycerin, Glycol

Distearate, Decyl

Glucoside, Aloe

Barbadensis Leaf Juice,

Lavandula Angustifolia

(Lavender) Oil,

Hydrolyzed Silk,

Acrylates Copolymer,

PEG-150 Pentaerythrityl

Tetrastearate, Caprylyl

Glycol,

Polyquaternium-10, PEG-6

Caprylic/Capric Glycerides,

Hexylene Glycol, Disodium

EDTA, Pentylene Glycol,

Ethylhexylglycerin,

Cetrimonium Chloride,

Propanediol, Alcohol Denat.,

Fragrance (Parfum), Benzyl

Benzoate, Butylphenyl

Methylpropional, Coumarin, Linalool

Biosilk H+B Shampoo

Biosilk Health + BeautyAntibacterial Shampoowith aloe vera, lavender & silk94% naturalKills 99.9% of germsFDA Registration #NDC 73740-7070-1sulfate and paraben freepH 5.5Made in the USA12 Fl OZ (355 mL)

* Please review the disclaimer below.