NDC 39892-0811 Medichoice Pvp

Povidone-iodine

NDC Product Information

Medichoice Pvp with NDC 39892-0811 is a a human over the counter drug product labeled by Owens & Minor Inc.. The generic name of Medichoice Pvp is povidone-iodine. The product's dosage form is swab and is administered via topical form.

Labeler Name: Owens & Minor Inc.

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.

Medichoice Pvp 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 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)
  • NONOXYNOL-10 (UNII: K7O76887AP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • POTASSIUM IODIDE (UNII: 1C4QK22F9J)
  • WATER (UNII: 059QF0KO0R)

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: Owens & Minor Inc.
Labeler Code: 39892
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: 08-29-2017 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.

Medichoice Pvp Product Label Images

Medichoice Pvp 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 USP,10% w/w

Purpose

Antiseptic

Use

For preparation of the skin prior to surgery and helps reduce bacteria that can potentially cause skin infection. Topical first aid antiseptic to help reduce the risk of skin infection in minor cuts, scrapes, and burns.

Warnings

For external use only.

Do Not Use

  • In the eyes on individuals who are allergic or sensitive to iodine over large areas of the body as a first aid antiseptic longer than one week unless directed by a doctor.

Consult A Doctor

  • In case of deep or puncture wounds, animal bites, or serious burns.

Stop Use And Consult A Doctor

  • If irritation or redness develops if the condition persists or gets worse infection occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For preparation prior to surgery


Clean the treatment area


Remove swab by stick


Apply to the operative site prior to surgery.


For use as a first aid antisepticClean the treatment area


Apply a small amount on the treatment area 1-3 times daily


May be covered with a sterile bandage


Let dry before covering.

Other Information

  • Store at room temperature.Avoid excessive heat.

Inactive Ingredient

Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxyno-10, Glycerine, Sodium Hydroxide, Potassium Iodide, Purified Water

* Please review the disclaimer below.