NDC 72189-224 Good Sense Artificial Tears

Polyvinyl Alcohol, Povidone

NDC Product Code 72189-224

NDC 72189-224-15

Package Description: 15 mL in 1 BOTTLE

NDC Product Information

Good Sense Artificial Tears with NDC 72189-224 is a a human over the counter drug product labeled by Direct Rx. The generic name of Good Sense Artificial Tears is polyvinyl alcohol, povidone. The product's dosage form is solution and is administered via ophthalmic form.

Labeler Name: Direct Rx

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.

Good Sense Artificial Tears 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 .6 g/100mL
  • POLYVINYL ALCOHOL, UNSPECIFIED .5 g/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 CHLORIDE (UNII: 451W47IQ8X)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Administration Route(s)

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

  • Ophthalmic - Administration to the external eye.

Product Labeler Information

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

Labeler Name: Direct Rx
Labeler Code: 72189
FDA Application Number: part349 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: 05-26-2021 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.

Good Sense Artificial Tears Product Label Images

Good Sense Artificial Tears 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 ingredientsPolyvinyl alcohol.....0.5%Povidone......0.6%

Otc - Purpose

PurposesPolyvinyl alcohol ...Eye lubricantPovidone ...Eye lubricant

Indications & Usage

Usesfor use as a protectant against further irritation or to relieve dryness of the eye

for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

WarningsFor external use onlyDo not use this product if solution changes color or becomes cloudyStop use and ask a doctor if you experienceeye pain

changes in vision

continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours
Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.When using this productto avoid contamination, do not touch tip of container to any surface

replace cap after using. Keep container tightly closed

remove contact lens before using

Dosage & Administration

DirectionsInstill 1 or 2 drops in the affected eye(s) as needed.

Other Safety Information

Other informationTamper Evident. Do not use this product if imprinted neckband is missing or broken.

RETAIN THIS CARTON FOR FUTURE REFERENCE

Store at 15º-30º C (59º-86ºF)

Inactive Ingredient

Inactive ingredientsbenzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic

* Please review the disclaimer below.