NDC 0498-0128 Pvp Iodine Swabs


NDC Product Code 0498-0128

NDC 0498-0128-46

Package Description: 10 AMPULE in 1 CARTON > .6 mL in 1 AMPULE (0498-0128-00)

NDC Product Information

Pvp Iodine Swabs with NDC 0498-0128 is a a human over the counter drug product labeled by Honeywell Safety Products Usa, Inc. The generic name of Pvp Iodine Swabs 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: 1037205.

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.

Pvp Iodine Swabs 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.

  • WATER (UNII: 059QF0KO0R)
  • NONOXYNOL-9 (UNII: 48Q180SH9T)

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: Honeywell Safety Products Usa, Inc
Labeler Code: 0498
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-21-2018 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.

Pvp Iodine Swabs Product Label Images

Pvp Iodine Swabs 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 solution USP, 10% (equivalent to 1% titratable iodine)


First aid antiseptic


First aid to help prevent the risk of infection in minor cuts, scrapes, and burns


For external use only

Do Not Use

  • In the eyesover large areas of the bodyon individuals who are allergic or sensitive to iodine

Ask A Doctor Before Use If You Have

  • Deep or puncture wounds,animal bitesserious burns

When Using This Product

Do not use longer than one wek unless directed by a doctor

Stop Use And Ask A Doctor If

  • Conditions persists or gets worseirritation and redness develops

Keep Out Of Reach Of Children.

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


  • Reverse cardboard sleeve, then crush at dot between thumb and forefinger. Allow solution to saturate tip and apply solution to injury.clean affected areaapply to affected area 1 to 3 times dailymay be covered with a sterile bandagediscard swab after single use

Other Information

  • Store at room temperature away from lightkeep from freezing or excessive heatdo not use if package is torn or open

Inactive Ingredients

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

* Please review the disclaimer below.