NDC 74955-054 Softie Soft And Smooth Handsoap Antibacterial White Tea

Benzalkonium Chloride

NDC Product Code 74955-054

NDC CODE: 74955-054

Proprietary Name: Softie Soft And Smooth Handsoap Antibacterial White Tea What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Benzalkonium Chloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 74955 - Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
    • 74955-054 - Softie Soft And Smooth Handsoap Antibacterial White Tea

NDC 74955-054-01

Package Description: 400 mL in 1 BOTTLE, PUMP

NDC Product Information

Softie Soft And Smooth Handsoap Antibacterial White Tea with NDC 74955-054 is a a human over the counter drug product labeled by Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi. The generic name of Softie Soft And Smooth Handsoap Antibacterial White Tea is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Softie Soft And Smooth Handsoap Antibacterial White Tea 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/100mL

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 LAURETH-3 SULFATE (UNII: BPV390UAP0)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)

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: Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
Labeler Code: 74955
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 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.

Softie Soft And Smooth Handsoap Antibacterial White Tea Product Label Images

Softie Soft And Smooth Handsoap Antibacterial White Tea 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%

Purpose

Antibacterial

Use

• For handwashing to decrease bacteria on the skin

Warnings: For External Use Only.

Avoid contact with eyes, if eye contact occurs, flush with water.Stop use and ask a doctor if irritation and redness develops.

Keep Out Of Reach Of Children.

If swallowed get medical help or contact a Poison Control Center right away.

Directions:

Pump into hands, lather vigorously for at least 15 seconds, rinse and dry thoroughly.

Inactive Ingredients

Aqua, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Coco-Glucoside (and) Glyceryl Oleate, Cocamide DEA (and) Glycerin, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate, Parfum, Citronellol, Linalool.

* Please review the disclaimer below.