NDC 74955-043 Softie Antibacterial Handsoap Aloe Vera And Pineapple
Benzalkonium Chloride Liquid Topical
NDC Product Code 74955-043
Proprietary Name: Softie Antibacterial Handsoap Aloe Vera And Pineapple 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.
Drug Use Information
Drug Use InformationThe drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
- This product is used as antibacterial
NDC Code Structure
- 74955 - Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi
- 74955-043 - Softie Antibacterial Handsoap Aloe Vera And Pineapple
NDC 74955-043-01
Package Description: 400 mL in 1 BOTTLE, PUMP
NDC Product Information
Softie Antibacterial Handsoap Aloe Vera And Pineapple with NDC 74955-043 is a human over the counter drug product labeled by Cosmolive Kozmetik Sanayi Ve Ticaret Anonim Sirketi. The generic name of Softie Antibacterial Handsoap Aloe Vera And Pineapple is benzalkonium chloride. The product's dosage form is liquid and is administered via topical form.
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 Antibacterial Handsoap Aloe Vera And Pineapple 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.
RxNorm Crosswalk
What is RxNorm?RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.
The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:
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)
- LIMONENE, (+)- (UNII: GFD7C86Q1W)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
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: 01-02-2021 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.
Softie Antibacterial Handsoap Aloe Vera And Pineapple Product Label Images
Softie Antibacterial Handsoap Aloe Vera And Pineapple 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
- Purpose
- Use
- Warnings:
- Keep Out Of Reach Of Children.
- Directions:
- Inactive Ingredients
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, D-Limonene, CI 42090, CI 19140.
* Please review the disclaimer below.