NDC 52410-4114 Medpride Prep Solution Topical Antiseptic Microbicide

Povidone-iodine

NDC Product Code 52410-4114

NDC 52410-4114-5

Package Description: 474 mL in 1 BOTTLE

NDC 52410-4114-6

Package Description: 3785 mL in 1 JUG

NDC Product Information

Medpride Prep Solution Topical Antiseptic Microbicide with NDC 52410-4114 is a a human over the counter drug product labeled by Shield Line Llc. The generic name of Medpride Prep Solution Topical Antiseptic Microbicide 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 Prep Solution Topical Antiseptic Microbicide 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 100 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • 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: 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: 05-13-2019 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 Prep Solution Topical Antiseptic Microbicide Product Label Images

Medpride Prep Solution Topical Antiseptic Microbicide 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% (equivalent to 1% available Iodine)

Purpose

Antiseptic

Uses

  • Health-care antiseptic for preparation of the skin prior to surgeryFirst aid antiseptic to help prevent infection in minor cuts, scrapes and burns

Warnings

For External Use Only

Do Not Use

  • In eyesAs a first antiseptic longer than one weekOn individuals who are allergic or sensitive to iodineApply over large areas of body

Discontinue Use And Call Your Doctor If

  • Irritation and redness develop and persists for more than 72 hoursCondition persists or get worse

Ask Your Doctor In Case Of

  • Deep or puncture woundsAnimal bitesSerious burns

Keep Out Of Reach Of Children

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

Directions

  • For preparation of the skin prior to surgery:Apply product to the operative site prior to surgeryAs a first aid antiseptic:Clean the affected areaApply a small amount of this product on the area 1-3 times dailyMay be covered with a sterile bandageIf bandaged, let dry first

Inactive Ingredients

Citric Acid, Sodium Citrate, Glycerin, Tween 80, Disodium Phosphate, Purified Water

* Please review the disclaimer below.