NDC 63517-400 Povidone-iodine Prep Pad

Povidone-iodine

NDC Product Code 63517-400

NDC 63517-400-83

Package Description: 10 BOX in 1 CARTON > 100 POUCH in 1 BOX > .56 g in 1 POUCH

NDC Product Information

Povidone-iodine Prep Pad with NDC 63517-400 is a a human over the counter drug product labeled by Cardinal Health 200, Inc.. The generic name of Povidone-iodine Prep Pad is povidone-iodine. The product's dosage form is solution and is administered via topical form.

Labeler Name: Cardinal Health 200, 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 Pad 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Cardinal Health 200, Inc.
Labeler Code: 63517
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: 08-05-2016 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 Prep Pad Product Label Images

Povidone-iodine Prep Pad 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% (equivalent to 1% titratable iodine)

Purpose

First Aid Antiseptic

Use

•first aid to help prevent skin infection in minor cuts, scrapes, and burns

Warnings

For external use only.





Allergy Alert: Do not apply to persons allergic to Iodine

Do Not Use

• in the eyes or apply over large areas of the body • longer than one week unless directed by a doctor

Ask A Doctor Before Use If You Have

• deep or puncture wounds • animal bites • serious burns

Stop Use And Consult A Doctor

If the condition persists or gets worse

Keep Out Of Reach Of Children.

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

Directions

• clean the affected area • apply a small amount of this product on the area 1-3 times daily • may be covered with a sterile bandage • if bandaged, let dry first

Other Information

• store at 15°-30°C (59°-86°F)

Inactive Ingredients

(purified) water, glycerol, nonylphenol ethoxylate, citric acid, sodium hydroxide

Package Labeling:

Packet Labeling:Box Labeling:Carton Labeling:

* Please review the disclaimer below.