NDC 73740-5001 Biosilk Gardenia

Benzalkonium Chloride

NDC Product Code 73740-5001

NDC 73740-5001-1

Package Description: 354.88 g in 1 BOTTLE, PUMP

NDC Product Information

Biosilk Gardenia with NDC 73740-5001 is a a human over the counter drug product labeled by Farouk Systems, Inc.. The generic name of Biosilk Gardenia is benzalkonium chloride. The product's dosage form is lotion and is administered via cutaneous form.

Labeler Name: Farouk Systems, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 Gardenia 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 .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.

  • BENZYL BENZOATE (UNII: N863NB338G)
  • BENZYL SALICYLATE (UNII: WAO5MNK9TU)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ALCOHOL (UNII: 3K9958V90M)
  • EUGENOL (UNII: 3T8H1794QW)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • DIMETHICONE 100 (UNII: RO266O364U)
  • C15-19 ALKANE (UNII: CI87N1IM01)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
  • WATER (UNII: 059QF0KO0R)
  • SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CETYL ALCOHOL (UNII: 936JST6JCN)

Administration Route(s)

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

  • Cutaneous - Administration to the skin.
  • 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: 08-24-2020 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 Gardenia Product Label Images

Biosilk Gardenia 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

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

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.

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

get medical help or contact a Poison Control Center immediately.

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.

Directions

apply a small amount to palm and rub hands together thoroughly

Uses

Use[s] to help reduce bacteria on the skin

recommended for routine use

Directions

Directions

apply a small amount to palm and rub hands together thoroughly

Inactive Ingredients

Inactive ingredients: Aqua/Water/Eau, Cetyl Alcohol,

Dimethicone, Propanediol, Cetearyl Alcohol, C15-19 Alkane,

Glycerin, Glyceryl Stearate SE, Ceteareth-20, Caprylyl Glycol,

Aloe Barbadensis Leaf Juice, Hydrolyzed Silk, Hexylene

Glycol, Dimethiconol, Butyrospermum Parkii (Shea) Butter,

Pentylene Glycol, Ethylhexylglycerin, Disodium EDTA,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium

Hydroxide, Alcohol Denat., Fragrance (Parfum), Benzyl

Benzoate, Benzyl Salicylate, Eugenol, Hydroxycitronellal

Biosilk Health + Care

Biosilk Health +Care Antibacterial Shield Lotion with Aloe Vera, Gardenia & Silk95% NaturalParaben FreeKills 99.9% of germsFDA Registration # NDC 73740-5001-1pH 5.5MADE IN THE USA12 flo oz (355 ml)

* Please review the disclaimer below.