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  4. NDC Product Code: 68786-418 Povidone Iodine Gel Swabstick

NDC 68786-418 Povidone Iodine Gel Swabstick

Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 68786-418?
  4. Povidone Iodine Gel Swabstick Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
68786-418
Proprietary Name:
Povidone Iodine Gel Swabstick
Non-Proprietary Name: [1]
Povidone Iodine Gel Swabstick
Substance Name: [2]
Povidone-iodine
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Sion Biotext Medical Ltd
    Labeler Code:
    68786
    Product Label ID:
    1058b4ff-c337-7a5a-e063-6394a90aca41
    FDA Application Number: [6]
    M003
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    02-01-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 68786-418?

    The NDC code 68786-418 is assigned by the FDA to the product Povidone Iodine Gel Swabstick which is a human over the counter drug product labeled by Sion Biotext Medical Ltd. The product's dosage form is gel and is administered via topical form. The product is distributed in a single package with assigned NDC code 68786-418-01 50 packet in 1 box / .3 ml in 1 packet. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Povidone Iodine Gel Swabstick?

    • Tear at notch • Remove applicator • Use only onceAs a first aid antiseptic:• Clean affected area• Apply 1 to 3 times daily• May be covered with a sterile bandage• If bandaged, let dry firstFor preoperative patient skin preparation:• Clean area• Apply to operative site prior to surgeryFor Venipuncture skin preparation:• Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. Continue this for a minimum of 30 seconds.• After scrubbing for 30 seconds, and using the same applicator, begin at the venipuncture site and move gradually outward in concentric circles to form a total prepped area measuring at least 3 inches in diameter.• Allow site to dry for approximately 30 seconds.• If the patient bend the arm, or if prepared site is touched with the fingers or with any other non-sterile object, the complete preparation must be repeated.

    What are Povidone Iodine Gel Swabstick Active Ingredients?

    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.
    • POVIDONE-IODINE 10 mg/mL - An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes.

    Which are Povidone Iodine Gel Swabstick UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Povidone Iodine Gel Swabstick Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Povidone Iodine Gel Swabstick?

    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 indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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] 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".