NDC 52380-4111 Aplicare Povidone-iodine Prep Pad

Povidone-iodine

NDC Product Code 52380-4111

NDC 52380-4111-1

Package Description: .5 mL in 1 PACKET

NDC 52380-4111-2

Package Description: .5 mL in 1 PACKET

NDC Product Information

Aplicare Povidone-iodine Prep Pad with NDC 52380-4111 is a a human over the counter drug product labeled by Aplicare, Inc.. The generic name of Aplicare Povidone-iodine Prep Pad is povidone-iodine. The product's dosage form is solution 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: 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.

Aplicare Povidone-iodine Prep Pad 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.

  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • NONOXYNOL-9 (UNII: 48Q180SH9T)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

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: Aplicare, Inc.
Labeler Code: 52380
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: 05-31-2017 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.

Aplicare Povidone-iodine Prep Pad Product Label Images

Aplicare Povidone-iodine Prep Pad 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

Antiseptic

Use

Antiseptic skin preparation

Directions

Apply locally as needed.

Other Information

  • Prep pad size: 1-1/4" × 1-1/2"1% titratable iodineNot made with natural rubber latexFor hospital or professional use only

Inactive Ingredients

Citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Otc - Do Not Use

  • Do not use if allergic to iodine or in the eyes

Other

  • For external use only

Otc - Ask Doctor

  • Ask a doctor before use if injuries are deep wounds, puncture wounds, or serious burns

Otc - Stop Use

  • Stop use and ask a doctor if infection occurs or if redness, irritation, swelling or pain persists or increases

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Storage And Handling

  • Avoid excessive heat. Store at room temperature.

* Please review the disclaimer below.