NDC 80202-311 Antibacterial Wipes
Didecyl Dimethyl Ammonium Chloride, Benzalkonium Chloride
NDC Product Code 80202-311
Proprietary Name: Antibacterial Wipes 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: Didecyl Dimethyl Ammonium Chloride, 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
- 80202 - Abby&finn Llc
- 80202-311 - Antibacterial Wipes
NDC 80202-311-40
Package Description: 324 g in 1 BAG
NDC Product Information
Antibacterial Wipes with NDC 80202-311 is a a human over the counter drug product labeled by Abby&finn Llc. The generic name of Antibacterial Wipes is didecyl dimethyl ammonium chloride, benzalkonium chloride. The product's dosage form is cloth and is administered via topical form.
Dosage Form: Cloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
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.
Antibacterial Wipes 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.
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.
- AMINO ACIDS, SOY (UNII: NWB9514AZM)
- PHENOXYETHANOL (UNII: HIE492ZZ3T)
- WATER (UNII: 059QF0KO0R)
- ISOPROPYL ALCOHOL (UNII: ND2M416302)
- BRONOPOL (UNII: 6PU1E16C9W)
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: Abby&finn Llc
Labeler Code: 80202
FDA Application Number: part333A 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: 02-03-2021 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.
Antibacterial Wipes Product Label Images
Antibacterial Wipes 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(S)
- Purpose
- Uses
- Do Not Use
- Otc - When Using
- Otc - Stop Use
- Otc - Keep Out Of Reach Of Children
- Directions
- Inactive Ingredients
Active Ingredient(S)
Didecyl Dimethyl Ammonium Chloride 0.5%Benzalkonium Chloride 0.1%
Purpose
AntibacterialAntibacterial
Uses
For hand sanitizing to decrease bacteria on the skin.
Do Not Use
- In the eyesIf you are allergic to any of the ingredients.
Otc - When Using
When using this product if eye contact occurs, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Storage. Store at room temperature.Dispensing. Peel resealable label back slowly. Reseal after use to avoid wipes drying out.Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping. To ensure best quality, use within 30 days of opening.Disposal. Dispose of used wipes in trash receptacle. Do not flush.
Inactive Ingredients
Ion Exchanged Water (Food Grade), Propan-2-ol, Bronopol, Natural Soybean Amino Acid (Food Grade), Phenoxyethanol.
* Please review the disclaimer below.