NDC 81906-221 Cofix Rx

Povidone-iodine Antiviral Nasal Spray

NDC Product Code 81906-221

NDC 81906-221-11

Package Description: 10 mL in 1 BOTTLE, SPRAY

NDC Product Information

Cofix Rx with NDC 81906-221 is a a human over the counter drug product labeled by Cofix-rx Llc. The generic name of Cofix Rx is povidone-iodine antiviral nasal spray. The product's dosage form is liquid and is administered via nasal form.

Labeler Name: Cofix-rx Llc

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.

Cofix Rx 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 1.25 mg/100mL

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.

  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • WATER (UNII: 059QF0KO0R)
  • GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • CARRAGEENAN (UNII: 5C69YCD2YJ)
  • XYLITOL (UNII: VCQ006KQ1E)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)

Administration Route(s)

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

  • Nasal - Administration to the nose; administered by way of the nose.

Product Labeler Information

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

Labeler Name: Cofix-rx Llc
Labeler Code: 81906
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: 05-14-2021 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".

* Please review the disclaimer below.

Cofix Rx Product Label Images

Cofix Rx 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(S)

Povidone-Iodine 1.25 % Purpose: Antiviral

Purpose

Antiviral

Use

Antiviral to temporarily prevent viral infection and transmission

Warnings

Ask a doctor before use if you have




■ had nose ulcers or nose surgery ■ had a nose injury that has not healed ■ trouble urinating due to an enlarged prostate ■ heart disease ■ thyroid disease ■ high blood pressure ■ diabetes ■ shellfish allergy

Do Not Use

■ if allergic to iodine or inactive ingredient(s) ■ in the eyes ■ on children less than 3 years old

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding ask a healthcare professional before use.

Otc - Stop Use

Stop use and ask a doctor if symptoms persist or worsen ■ swelling, infection, rash, or fever occurs

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

■ Adults and children over 6 years of age: 1 spray in each nostril not more than 3 times in any 24-hour period ■ Children under 6 years of age: consult a doctor ■ To use shake well, remove cap, spray directly up nostril quickly and firmly. Do not tilt head backward while spraying. Wipe spray nozzle clean and secure cap following use. Do not share applicators.

Other Information

Protect from freezing and excessive heat ■ store at room temperature ■ may stain clothing ■ avoid contact with jewelry ■ Keep the carton for complete warning and information

Inactive Ingredients

Carrageenan, gellan gum, polysorbate, purified water, sodium hydroxide, vitamin D3, xylitol

* Please review the disclaimer below.