NDC 61333-205 Lights Povindone Iodine Scrub

Povidone-iodine

NDC Product Code 61333-205

NDC Code: 61333-205

Proprietary Name: Lights Povindone Iodine Scrub What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Povidone-iodine What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 61333 - Lights Medical Manufacture Co., Ltd.
    • 61333-205 - Lights Povindone Iodine Scrub

NDC 61333-205-01

Package Description: 118 g in 1 BOTTLE

NDC Product Information

Lights Povindone Iodine Scrub with NDC 61333-205 is a a human over the counter drug product labeled by Lights Medical Manufacture Co., Ltd.. The generic name of Lights Povindone Iodine Scrub is povidone-iodine. The product's dosage form is solution and is administered via topical form.

Labeler Name: Lights Medical Manufacture Co., Ltd.

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.

Lights Povindone Iodine Scrub 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 .75 g/100g

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)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)

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: Lights Medical Manufacture Co., Ltd.
Labeler Code: 61333
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: 07-18-2019 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: 12-31-2020 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.

Lights Povindone Iodine Scrub Product Label Images

Lights Povindone Iodine Scrub 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

Active Ingredient: Povidone-Iodine USP (7.5%)

Otc - Purpose

Purpose: Antiseptic

Indications & Usage

Use:Antiseptic skin preparation

Warnings

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 skiin irritation.

Otc - Ask Doctor

Ask a doctor before use if injuries are deep or puncture woundsSerious burnsStop use and ask a doctor if Redness, irritation, swelling or pain persisits or increasesInfection occurs

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

Directions:Apply locally as needed.

Other Safety Information

  • Other informationStore at room temperature0.75% available iodineLatax freeFor hospital or professional use only

Inactive Ingredient

Inactive IngredientCitric acid, purified water, Disodium hydrogen phosphate

* Please review the disclaimer below.

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