NDC 80660-002 Vipy Antibacterial Sanitizing Wet Wipes Swab

Benzalkonium Chloride Cloth

NDC Product Code 80660-002

NDC CODE: 80660-002

Proprietary Name: Vipy Antibacterial Sanitizing Wet Wipes Swab 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 Cloth 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

  • 80660 - Vip Sales & Marketing Llc
    • 80660-002 - Vipy Antibacterial Sanitizing Wet Wipes

NDC 80660-002-80

Package Description: 80 PATCH in 1 BAG > 5.67 g in 1 PATCH

NDC Product Information

Vipy Antibacterial Sanitizing Wet Wipes Swab with NDC 80660-002 is a a human over the counter drug product labeled by Vip Sales & Marketing Llc. The generic name of Vipy Antibacterial Sanitizing Wet Wipes Swab is benzalkonium chloride cloth. The product's dosage form is swab and is administered via topical form.

Labeler Name: Vip Sales & Marketing Llc

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab 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.

Vipy Antibacterial Sanitizing Wet Wipes Swab 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 .15 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • ALLANTOIN (UNII: 344S277G0Z)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • DEXPANTHENOL (UNII: 1O6C93RI7Z)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)

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.
  • 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: Vip Sales & Marketing Llc
Labeler Code: 80660
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: 09-30-2020 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.

Vipy Antibacterial Sanitizing Wet Wipes Swab Product Label Images

Vipy Antibacterial Sanitizing Wet Wipes Swab 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

Purpose

Antiseptic

Active Ingredient

Benzalkonium Chloride 0.15%

Uses

  • For hand washing to decrease bacteria on the skin. Recommended for repeat use.

Warnings

  • For external use only.Keep out of reach of eyes. If contact occurs, rinse thoroughly with water.Do not use if you are allergic to any of the ingredients.Discontinue use if irritation or redness develops, and if condition persists for more than 72 hours consult a physician.Do not use in children under 2 months of age.

Directions Of Use

  • Open resealable label and pull one sheet from pack. Thoroughly clean hands or affected area and discard in receptacle, and do not flush. Allow to dry without wiping. Be sure to reseal label complete to retain moisture.

Other Information

  • Store at room temperature.

Keep Out Of Reach Of Children

  • Unless under adult supervision.If swallowed, get medical help, or contact a Poison Control Center immediately.

Inactive Ingredients

  • Water (Aqua), Aloe Barbadensis Leaf Juice, Allantoin, Benzoic Acid, Citric Acid, Cocamidopropyl Betaine, Dehydroacedic Acid, Dicaprylyl Carbonate, Glycerin, Glyceryl Oleate, Lauryl Glucoside, Olus Oil, Panthenol, Parfum, Phenoxyethanol, Polyglyceryl-2-Dipolyhydroxystearate, Polysorbate 20, Propylene Glycol, Tocopheryl Acetate

* Please review the disclaimer below.