NDC 39892-0809 Povidone-iodine Prep

Povidone-iodine

NDC Product Code 39892-0809

NDC 39892-0809-1

Package Description: 1.5 mL in 1 PACKET

NDC Product Information

Povidone-iodine Prep with NDC 39892-0809 is a a human over the counter drug product labeled by Owens & Minor Distribution, Inc.. The generic name of Povidone-iodine Prep is povidone-iodine. The product's dosage form is solution and is administered via topical form.

Labeler Name: Owens & Minor Distribution, Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Povidone-iodine Prep 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 100 mg/mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)

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 Distribution, Inc.
Labeler Code: 39892
FDA Application Number: part333C 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-01-2019 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.

Povidone-iodine Prep Product Label Images

Povidone-iodine Prep 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%

Purpose

Antiseptic

Use

Antiseptic skin preparation

Warnings

For external use only

Do Not Use

• if allergic to iodine


• in the eyes

Ask A Doctor Before Use

If injuries are • deep or puncture wounds • serious burns

Stop Use And Ask A Doctor If

• infection occurs • redness, irritation, swelling or pain persists or increases  Avoid pooling beneath patientAvoid excessive heat. Store at room temperature.

Keep Out Of Reach Of Children.

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

Directions

Apply locally as needed

Other Information

• 1% titratable iodine • for hospital or professional use only

Inactive Ingredients

Purified water, Glycerin, Nonyl nonoxynol-10

* Please review the disclaimer below.

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