NDC 73921-037 L-topical Povidone Iodine, 7.5% Scrub

Povidone Iodine

NDC Product Code 73921-037

NDC CODE: 73921-037

Proprietary Name: L-topical Povidone Iodine, 7.5% 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

  • 73921 - Global Pharma Healthcare Private Limited
    • 73921-037 - L-topical Povidone Iodine, 7.5% Scrub

NDC 73921-037-04

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

L-topical Povidone Iodine, 7.5% Scrub with NDC 73921-037 is a a human over the counter drug product labeled by Global Pharma Healthcare Private Limited. The generic name of L-topical Povidone Iodine, 7.5% Scrub is povidone iodine. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Global Pharma Healthcare Private Limited

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.

L-topical Povidone Iodine, 7.5% 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 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.

  • AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)
  • NONOXYNOL-9 (UNII: 48Q180SH9T)
  • 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: Global Pharma Healthcare Private Limited
Labeler Code: 73921
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: 04-01-2021 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".

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L-topical Povidone Iodine, 7.5% Scrub Product Label Images

L-topical Povidone Iodine, 7.5% 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

Active Ingredient

Povidone-iodine, 7.5% (0.75% available iodine)

Purpose

Antiseptic

Uses

• For preparation of the skin prior to surgery • Helps to reduce bacteria that potentially can cause skin infection • For handwashing to reduce bacteria on the skin • Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

For external use onlyDo not use this product in the eyesWhen using this product• Prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions • In pre-operative prepping avoid “pooling” beneath the patientStop use and ask a doctor• If irritation and redness develop • In rare instances of local irritation or sensitivity

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

A. Surgical hand scrub:• Wet hands with water • Spread about 5 cc (1 teaspoonful) of Scrub over both hands and forearms • Without adding more water, scrub thoroughly for 2 1/2 to 3 minutes • Use a sponge if desired. Clean thoroughly under fingernails. • Add a little water and develop copious suds. Rinse thoroughly under running water. • Repeat the entire procedure using another 5 cc of ScrubB. Antiseptic hand wash:• Wet hands with water and pour about 5 cc of Scrub on hands • Rub hands vigorously together for at least 15 seconds, covering all surfaces • Rinse and dry with a disposable towelC. Patient pre-operative skin preparation:• Single use only • Wet skin with water • Apply Scrub (1 cc is sufficient to cover an area of 20-30 square inches), develop lather and scrub thoroughly for about 5 minutes • Rinse off using sterile gauze saturated with water • The area may then be painted with BETADINE Solution and allowed to dry

Other Information

• Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)• Store in original container

Inactive Ingredients

Ammonium nonoxynol-4 sulfate, nonoxynol-9, purified water, sodium hydroxide

Questions?

Call toll-free 1-800-572-6632, Weekdays 7:00 AM - 5.30 PM EST.

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