NDC 67618-182 Betadine Antiseptic Oral Rinse

Povidone-iodine

NDC Product Information

Betadine Antiseptic Oral Rinse with NDC 67618-182 is a a human over the counter drug product labeled by Avrio Health L.p.. The generic name of Betadine Antiseptic Oral Rinse is povidone-iodine. The product's dosage form is solution and is administered via oral form.

Labeler Name: Avrio Health L.p.

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.

Betadine Antiseptic Oral Rinse 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 .05 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)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Avrio Health L.p.
Labeler Code: 67618
FDA Application Number: part356 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: 02-08-2021 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 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.

Betadine Antiseptic Oral Rinse Product Label Images

Betadine Antiseptic Oral Rinse 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

Drug Facts

Active ingredientPovidone-iodine,
0.5% (0.05% available iodine)

Purpose

Oral
Antiseptic

Uses

  • For preparation of the oral mucosa prior to injection, dental
  • Surgery, or tooth extraction

Do Not Use This Product

  • For more than 7 days unless directed by a dentist or doctorin children under 12 years of age unless directed by a dentist
  • Or doctorif you are allergic to povidone-iodine or any other ingredients
  • In this productif you have any thyroid conditions

When Using This Product

  • Do not get into eyes. If contact occurs, rinse eyes thoroughly
  • With water. If irritation persists, consult a doctordo not swallowdo not use with hydrogen peroxide

Stop Use And Ask A Doctor If

  • Symptoms do not improve in 7 daysirritation, pain, or redness persists or worsensswelling, rash, or fever develops

Otc - Pregnancy Or Breast Feeding

If pregnant
or breast-feeding, ask a health professional before use.

Directions

  • Use full strengthApply 10 to 20 milliliters of solution to the operative
  • Site. Instruct the patient to rinse for 30 seconds and then spit out.Wait 2 minutes, and apply another 10 to 20 milliliters of
  • Solution to the operative site. Instruct the patient to rinse again
  • For 30 seconds and then spit out.With a standard syringe and a blunt, angulated needle, irrigate
  • The operative site and the surrounding gingival mucosa for 1 minute
  • With 10 to 20 milliliters of the solution. Instruct the patient to
  • Spit out the solution after the irrigation procedure.

Other Information

  • Store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C
  • (59⁰-86⁰F)may stain clothing or dental workavoid contact with jewelry, especially silver

Inactive Ingredients

Citric acid,
flavor, glycerin, propylene glycol, purified water, saccharin sodium,
sodium hydroxide

* Please review the disclaimer below.