NDC 68786-140 Povidone Iodine

Povidone-iodine

NDC Product Code 68786-140

NDC 68786-140-01

Package Description: 10 BOX in 1 CASE > 100 PACKET in 1 BOX > 1 SWAB in 1 PACKET

NDC Product Information

Povidone Iodine with NDC 68786-140 is a 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. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 797730.

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.

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.

  • NONOXYNOL-9 (UNII: 48Q180SH9T)
  • 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: Sion Biotext Medical Ltd
Labeler Code: 68786
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: 04-17-2013 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 - 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 Label Images

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

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 eyesAs a first aid antiseptic for longer than 1 weekOver large areas of the body

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsAnimal bitesSerious burns

Stop Use And Ask A Doctor If

  • Condition worsens or persists for more than 72 hoursIrritation 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 notchRemove applicatorUse only onceAs a first aid antispeticClean affected areaapply 1-3 times dailyMay be covered with a sterile bandageIf bandaged, let dry first.For preoperative patient skin preparationClean areaApply to operative site prior to surgery using applicator

Other Information

  • Store at room temperatureAvoid excessive heat

Inactive Ingredients

Nonoxynol-9, water

* Please review the disclaimer below.