NDC 68786-130 Povidone Iodine
Povidone-iodine Swab Topical

Product Information

Product Code68786-130
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.
Povidone Iodine
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 FormSwab - 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.
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.
Sion Biotext Medical Ltd
Labeler Code68786
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.
part333A
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.
04-17-2013
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

Usage Information


Product Packages

NDC 68786-130-01

Package Description: 50 PACKET in 1 BOX > 1 SWAB in 1 PACKET

NDC 68786-130-02

Package Description: 25 PACKET in 1 BOX > 3 SWAB in 1 PACKET

NDC 68786-130-03

Package Description: 50 PACKET in 1 BOX > 1 SWAB in 1 PACKET

NDC 68786-130-04

Package Description: 50 PACKET in 1 BOX > 1 SWAB in 1 PACKET

NDC 68786-130-05

Package Description: 25 PACKET in 1 BOX > 3 SWAB in 1 PACKET

NDC 68786-130-06

Package Description: 50 PACKET in 1 BOX > 1 SWAB in 1 PACKET

Product Details

Povidone Iodine is a human over the counter drug product labeled by Sion Biotext Medical Ltd. The generic name of Povidone Iodine is povidone-iodine. The product's dosage form is swab and is administered via topical form.


What are Povidone Iodine Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.

  • NONOXYNOL-9 (UNII: 48Q180SH9T)
  • WATER (UNII: 059QF0KO0R)


* Please review the disclaimer below.

Povidone Iodine 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 10%


Purpose



Antiseptic


Uses



  • Antiseptic cleanser to help prevent infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infection.

Warnings



For External Use Only.


Do Not Use



  • In the eyes
  • As a first aid antiseptic for longer than 1 week
  • Over large areas of the body

Ask A Doctor Before Use If You Have



  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Stop Use And Ask A Doctor If



  • Condition worsens or persists for more than 72 hours
  • Irritation and redness develops

Keep Out Of Reach Of Children



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


Directions



  • Tear at notch
  • Remove applicator
  • Use only once

  • As a first aid antispetic

    • Clean affected area
    • apply 1-3 times daily
    • May be covered with a sterile bandage
    • If bandaged, let dry first.
    • For preoperative patient skin preparation

      • Clean area
      • Apply to operative site prior to surgery using applicator

Other Information



  • Store at room temperature
  • Avoid excessive heat

Inactive Ingredients



Nonoxynol-9, water


Principal Display Panel



50

Packets

Povidone-Iodine

Swabsticks

Antispetic/Germicide

For External Use Only

Sion Biotext

Medical Ltd.


* Please review the disclaimer below.