NDC 81584-1102 Povidone Iodine

Povidone-iodine

NDC Product Code 81584-1102

NDC 81584-1102-1

Package Description: 1 TUBE in 1 CARTON > 28.35 g in 1 TUBE

NDC Product Information

Povidone Iodine with NDC 81584-1102 is a a human over the counter drug product labeled by Dr Radows. The generic name of Povidone Iodine is povidone-iodine. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 312563.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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 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.


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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

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: Dr Radows
Labeler Code: 81584
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: 06-30-2021 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: 12-31-2022 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 - NO 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".

* Please review the disclaimer below.

Povidone Iodine 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

Other

DRUG FACTS

Active Ingredient

Povidone Iodine USP10% w/w (available iodine 1%)

Purpose

Antiseptic-germicidal

Uses

  • For the treatment of:
  • Minor wounds
  • Infections
  • Kills bacteria promptly

Warnings

For external use only.

Do Not Use

  • Over large areas of the body
  • If you are allergic to any of the ingredients
  • Longer than 1 week unless directed by a doctor

When Using This Product

  • Avoid contact with eyes.

Ask A Doctor Before Use If You Have

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Stop Use And Ask A Doctor If

  • Redness, irritation or swelling occurs or pain persists

Keep This And All Drugs Out Of The Reach Of Children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

  • Apply directly to affected area
  • May be bandaged

Other Information

  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.
  • For control no. and expiration date, see carton and/or crimp of tube.
  • Will not stain natural fabrics.
  • Protect from freezing.

Inactive Ingredients

Glycerin, PEG-6, PEG-32, propylene glycol

Questions?

Call (386) 414- 1809Distributed by Dr Radow's PO Box 952 Deland FL, 32721-0952

* Please review the disclaimer below.