NDC 73857-005 Theorie Moroccan Fig Nourishing Hand Wash

Benzalkonium Chloride

NDC Product Code 73857-005

NDC 73857-005-00

Package Description: .4 kg in 1 BOTTLE, PUMP

NDC Product Information

Theorie Moroccan Fig Nourishing Hand Wash with NDC 73857-005 is a a human over the counter drug product labeled by Dynastis, Llc. The generic name of Theorie Moroccan Fig Nourishing Hand Wash is benzalkonium chloride. The product's dosage form is soap and is administered via topical form.

Labeler Name: Dynastis, Llc

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.

Theorie Moroccan Fig Nourishing Hand Wash 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 .0013 kg/kg

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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)
  • GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
  • POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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.

Product Labeler Information

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

Labeler Name: Dynastis, Llc
Labeler Code: 73857
FDA Application Number: part333E What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-01-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Theorie Moroccan Fig Nourishing Hand Wash Product Label Images

Theorie Moroccan Fig Nourishing Hand Wash 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

Drug Facts

Benzalkonium Chloride 0.13%

Uses

For hand washing to decrease bacteria that can potentially cause disease.

Warnings

For external use only. If swallowed, get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Do Not Use

• in children less than 2 months of age• on open skin wounds

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Children must be supervised when using this product.

Indications & Usage

Stop use and ask a doctor if: irritation or rash occurs. These maybe signs of a serious condition.

Directions

For maximum efficiency, pump the product into wet hands, lather vigorously, sinse and dry.

Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Coco Glucoside, Glycerin, Polysorbate-20, PEG-150 Pentaerythrityl Tetrastearate, Guar Hydroxypropyltrimonium Chloride, Polyquaternium-10, Sodium Hyaluronate, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Fragrance.

Other Information

Store at room temperature 68°F to 77°F (20° to 25°C)Do not expose to excessive heat.You may report a serious adverse reaction to: Hautehouse, LLC, 909 NW Terrace, Fort Lauderdale, FL 33311 USA

For Questions

HAUTEHOUSE INC.909 NW TerraceFort Lauderdale, FL 33311 USA+1 (954) 376-8966www.hautehouse.com

* Please review the disclaimer below.