NDC 81280-003 Povidone-iodine

Povidone-iodine

NDC Product Code 81280-003

NDC 81280-003-01

Package Description: 500 POUCH in 1 CARTON > 1 APPLICATOR in 1 POUCH > 2.5 mL in 1 APPLICATOR

NDC 81280-003-03

Package Description: 500 POUCH in 1 CARTON > 3 APPLICATOR in 1 POUCH > 4.5 mL in 1 APPLICATOR

NDC Product Information

Povidone-iodine with NDC 81280-003 is a a human over the counter drug product labeled by Mazza Healthcare, Llc. The generic name of Povidone-iodine is povidone-iodine. The product's dosage form is swab and is administered via topical form.

Labeler Name: Mazza Healthcare, Llc

Dosage Form: Swab - A small piece of relatively flat absorbent material that contains a drug. A swab may also be attached to one end of a small stick. A swab is typically used for applying medication or for cleansing.

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 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 .1 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NONOXYNOL-10 (UNII: K7O76887AP)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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: Mazza Healthcare, Llc
Labeler Code: 81280
FDA Application Number: part333C 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-01-2021 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: 12-31-2022 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.

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

Active Ingredient

Povidone-Iodine, USP, 10% v/v(equivalent to 1% titratable iodine)

Purpose

Antiseptic

Uses

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

Warnings

For external use only

Do Not Use

  • In the eyes
  • On individuals who are allergic or sensitive to iodine
  • Over large areas of the body
  • As first aid antiseptic longer than 1 week unless directed by doctor
  • Discontinue use if irritation and redness develop.

Otc - Ask Doctor

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.

Otc - Stop Use

Stop use and consult a doctor if the condition persists or gets worse.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Clean the affected area
  • For preparation of the skin prior to surgery, apply product to the operative site
  • Apply product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information

Store at room temperature 59-86ºF (15-30ºC).

Inactive Ingredients

Citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide
Mazza Healthcare, LLC 1-877-629-9242

* Please review the disclaimer below.