NDC 52380-1738 Aplicare Povidone Iodine

Povidone Iodine

NDC Product Information

Aplicare Povidone Iodine with NDC 52380-1738 is a a human over the counter drug product labeled by Aplicare Products, Llc.. The generic name of Aplicare Povidone Iodine is povidone iodine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Aplicare Products, Llc.

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.

Aplicare Povidone Iodine 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/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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
  • NONOXYNOL-10 (UNII: K7O76887AP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • 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: Aplicare Products, Llc.
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: 09-01-1998 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 11-06-2022 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Aplicare Povidone Iodine Product Label Images

Aplicare Povidone Iodine 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

Otc - Active Ingredient

Povidone-iodine USP 10%

Otc - Purpose

Antiseptic

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.

Warnings

Do not use if allergic to iodineFor external use onlyDo not use in eyesAvoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.

Otc - Stop Use

  • Stop use and ask a doctor ifredness, irritation, swelling or pain persists or increasesinfection occurs

Otc - Ask Doctor

  • Ask a doctor before use if injuries aredeep or puncture woundsserious burns

Otc - Questions

Questions or comments?1-800-760-3236 (Mon to Fri 8:30 AM - 5:00 PM EST)

Indications & Usage

Use• antiseptic skin preparation• single use when used for patient preoperative skin preparation and/or preinjection indications

Dosage & Administration

Directions apply locally as needed.

Other Safety Information

Other information• 1% titratable iodine• latex free• for professional or professional use only

Inactive Ingredient

• disodium phosphate• glycerin• hydroxyethylcellulose• nonoxynol-10• simethicone• water

* Please review the disclaimer below.