NDC 39892-0808 Medichoice Povidone-iodine Prep Pad
Povidone-iodine Cloth Topical

Product Information

Medichoice Povidone-iodine Prep Pad is a human over the counter drug product labeled by Owens & Minor Distribution, Inc.. The generic name of Medichoice Povidone-iodine Prep Pad is povidone-iodine. The product's dosage form is cloth and is administered via topical form.

Product Code39892-0808
Proprietary Name 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.
Medichoice Povidone-iodine Prep Pad
Non-Proprietary Name 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.
Povidone-iodine
Product Type 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.
Human Otc Drug
Dosage FormCloth - A large piece of relatively flat, absorbent material that contains a drug. It is typically used for applying medication or for cleansing.
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.
Owens & Minor Distribution, Inc.
Labeler Code39892
FDA Application Number 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.
part333E
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
03-04-2019
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Medichoice Povidone-iodine Prep Pad?


Product Packages

NDC 39892-0808-1

Package Description: 1 POUCH in 1 PACKET > 1 mL in 1 POUCH

Product Details

What are Medichoice Povidone-iodine Prep Pad Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • POVIDONE-IODINE 100 mg/mL - An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes.

Medichoice Povidone-iodine Prep Pad Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Medichoice Povidone-iodine Prep Pad Inactive Ingredients UNII Codes

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.

* Please review the disclaimer below.

Medichoice Povidone-iodine Prep Pad Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Active Ingredient



Povidone-iodine USP 10%


Purpose



Antiseptic


Use



Antiseptic skin preparation


Warnings



For external use only.


Do Not Use



  • if allergic to iodine

Ask A Doctor Before Use



if injuries are deep wounds, puncture wounds, or serious burn


Stop Use And Ask A Doctor



if infection occurs or if redness, irritation, swelling or pain persists or increases


Keep Out Of Reach Of Children.



In case of accidental ingestion, seek professional assistance or consult a poison control center Immediately

  • Avoid excessive heat. Store at room temperature.

Directions



  • Apply locally as needed.

Other Information



  • 1% titratable iodine
  • For hospital or professional use only.

Inactive Ingredients



Purified water, Glycerin, Nonyl nonoxynol-10, Citric acid, Sodium hydroxide


Package Labeling:




* Please review the disclaimer below.