NDC 72728-001 Providone-iodine Prep Pads

Povidone-iodine Prep Pads

NDC Product Code 72728-001

NDC Code: 72728-001

Proprietary Name: Providone-iodine Prep Pads 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: Povidone-iodine Prep Pads 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.


Code Structure
  • 72728 - A2z Products, Llc
    • 72728-001 - Providone-iodine Prep Pads

NDC 72728-001-00

Package Description: 1 CLOTH in 1 PACKET

NDC 72728-001-01

Package Description: 100 CLOTH in 1 BOX

NDC 72728-001-02

Package Description: 200 CLOTH in 1 BOX

NDC Product Information

Providone-iodine Prep Pads with NDC 72728-001 is a a human over the counter drug product labeled by A2z Products, Llc. The generic name of Providone-iodine Prep Pads is povidone-iodine prep pads. The product's dosage form is cloth and is administered via topical form.

Labeler Name: A2z Products, Llc

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.


Providone-iodine Prep Pads 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.

  • POVIDONE-IODINE 10 mg/1
  • POVIDONE-IODINE 10 mg/1
  • POVIDONE-IODINE 10 mg/1

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)
  • NONOXYNOL-9 (UNII: 48Q180SH9T)

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.
  • 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: A2z Products, Llc
Labeler Code: 72728
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: 02-15-2019 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: 12-31-2020 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.

Providone-iodine Prep Pads Product Label Images

Providone-iodine Prep Pads 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

Povidone Iodine 10%

Purpose

Antiseptic

Uses

Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes, and burnsFor preparation of the skin prior to surgeryHelps reduce bacteria that can potentially cause skin infection

Warnings

For External Use Only.

Do Not Use

In the eyesAs a first aid anticeptic for more than 1 weekOver large areas of the body

Ask A Doctor Before Use If You Have

Deep puncture woundsAnimal bitesSerious wounds

Stop Use And Ask A Doctor If

Condition worsens or persists for more than 72 hoursIrritation and redness develops

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

Tear a notchRemove applicatorUse only once

As A First Aid Antiseptic

Clean affected areaapply 1 to 3 times dailyMay be covered with sterile bandageIf bandaged, let dry first

For Preoperative Patient Skin Preparation

Clean areaApply to operative site prior to surgery using applicator

Other Information

Store at room temperatureAvoid excessive heat

Inactive Ingredients

Nonoxynol-9, water

Dosage & Administration

Sterile unless poch is opened or damaged.Saturated with 10% Povidone Iodine.

Indications & Usage

First aid to help prevent infection in minor cuts, scrapes, and burns.

Povidone-Iodine Prep Pads - 1Pad

Povidone-Iodine Prep Pads



For External Use OnlyApply topically as neededDiscard after single useSterile unless pouch is opened or damagedSaturated with 10% Povidone Iodine1 PadMedium

* Please review the disclaimer below.

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