NDC 65517-0036 Povidone-iodine Gel Swabstick

Povidone Iodine

NDC Product Information

Povidone-iodine Gel Swabstick with NDC 65517-0036 is a a human over the counter drug product labeled by Dukal Corporation. The generic name of Povidone-iodine Gel Swabstick is povidone iodine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Dukal Corporation

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.

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 Gel Swabstick 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 mg/g

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-10 (UNII: K7O76887AP)
  • POTASSIUM IODIDE (UNII: 1C4QK22F9J)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)

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.
  • 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: Dukal Corporation
Labeler Code: 65517
FDA Application Number: part333E 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: 12-02-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Povidone-iodine Gel Swabstick Product Label Images

Povidone-iodine Gel Swabstick 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%

Purpose

Antispetic

Use

Antiseptic Skin Preparation

Warnings

For External Use Only

Do Not Use

  • If allergic to Iodinein the eyes

Ask A Doctor Before Use If Injuries Are

  • Deep or puncture woundsSerious burn

Stop Use And Ask Doctor If

  • Infection occursredness, irritation or swelling develops

Keep Out Of Reach Of Children

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

Directions

  • Apply product to skin as neededsee product box for additional directions

Other Information

  • 1% titratable iodineAvoid excessive heatStore at room temperatureFor hospital or professional use onlyNot made with natural rubber latex

Inactive Ingredients

Alkyl glucoside, anhydrous citric acid, aonoxynol-10, glycerin, hydroxyethyl cellulose, potassium iodine, sodium hydroxide, water

Dukal Povidone-Iodine Gel Swabstick

DUKAL™

CORPORATION
NDC 65517-0036-1REF 899Hold Upright and Tear HerePOVIDONE-IODINEGel SwabstickReady Gel 1X™4" (10.2cm)Saturated SwabstickDrug FactsActive ingredients Purpose

Povidone Iodine USP 10% Antiseptic
Use Patient preoperative skin preparation: Helps toreduce bacterial that potentially can cause skin infection1/Pouch 2Made in China D07310901 Rev2

* Please review the disclaimer below.