NDC 52410-4116 Medpride Povidone Iodine Scrub Solution Skin Cleanser

Povidone-iodine

NDC Product Code 52410-4116

NDC Code: 52410-4116

Proprietary Name: Medpride Povidone Iodine Scrub Solution Skin Cleanser 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.

Non-Proprietary Name: Povidone-iodine 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.

NDC Code Structure

  • 52410 - Shield Line Llc
    • 52410-4116 - Medpride Povidone Iodine Scrub Solution

NDC 52410-4116-5

Package Description: 474 mL in 1 BOTTLE

NDC 52410-4116-6

Package Description: 3785 mL in 1 JUG

NDC Product Information

Medpride Povidone Iodine Scrub Solution Skin Cleanser with NDC 52410-4116 is a a human over the counter drug product labeled by Shield Line Llc. The generic name of Medpride Povidone Iodine Scrub Solution Skin Cleanser is povidone-iodine. The product's dosage form is solution and is administered via topical form.

Labeler Name: Shield Line Llc

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.

Medpride Povidone Iodine Scrub Solution Skin Cleanser 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 75 mg/mL

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.

  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MONOETHANOLAMINE (UNII: 5KV86114PT)
  • WATER (UNII: 059QF0KO0R)
  • LAURYL SULFATE (UNII: DIQ16UC154)
  • HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)

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: Shield Line Llc
Labeler Code: 52410
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: 05-14-2019 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.

Medpride Povidone Iodine Scrub Solution Skin Cleanser Product Label Images

Medpride Povidone Iodine Scrub Solution Skin Cleanser 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, 7.5% (equivalent to .75% available Iodine)

Purpose

Antiseptic

Uses

  • Washing whenever a germicidal soap is required
  • Maximum degerming of the hands

Warnings:

For External Use Only

Keep Out Of Reach Of Children

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

Directions

  • Apply necessary quantity
  • Degasa Surgical Scrub on area to wash on patients for preoperative or for operating personnel.
  • Distributing thoroughly
  • Degasa Surgical Scrub on the desired area, rubbing at least 5 minutes.
  • On patients, rinse off with a sterile gauze saturated with water. On operating personnel, rinse the hands under running water, clean under fingernails use brush if desired.On operations personnel complete disinfection with another wash with the same way.

Inactive Ingredients

Disodium Phosphate, Glycerin, Hydroxyethyl Cellulose Monoethanolamine, N-Dodecyl Sulphate, Purified Water

* Please review the disclaimer below.

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