NDC 70000-0060 Leader Povidone-iodine 10% Topical Solution

Povidone Iodine Prep Solution 10%

NDC Product Information

Leader Povidone-iodine 10% Topical Solution with NDC 70000-0060 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Povidone-iodine 10% Topical Solution is povidone iodine prep solution 10%. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Cardinal Health

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Leader Povidone-iodine 10% Topical Solution 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

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.
  • 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: Cardinal Health
Labeler Code: 70000
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: 09-25-2020 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 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.

Leader Povidone-iodine 10% Topical Solution Product Label Images

Leader Povidone-iodine 10% Topical Solution 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

Warnings

For external use only

Do Not Use

  • If allergic to iodine in the eyes

Stop Use And Ask A Doctor If

  • Irritation and redness developcondition persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Inactive Ingredients

Citric Acid Anhydrous, Disodium Phosphate Anhydrous, Glycerin, Polysorbate 80, Puried Water, Sodium Citrate USP

Active Ingredient

Povidone-iodine 10%

Purpose

Healthcare Antiseptic

Use

For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

Directions

Clean the area. Apply product to the operative site prior to surgery.

Other

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

Questions?

1-888-396-2739

* Please review the disclaimer below.