NDC 67172-502 Clear Eyes Advanced Dry And Itchy

Glycerin

NDC Product Code 67172-502

NDC Code: 67172-502

Proprietary Name: Clear Eyes Advanced Dry And Itchy 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: Glycerin 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.


Code Structure
  • 67172 - Prestige Brands Holdings, Inc.
    • 67172-502 - Clear Eyes Advanced Dry And Itchy

NDC 67172-502-15

Package Description: 1 BOTTLE, DROPPER in 1 CARTON > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Clear Eyes Advanced Dry And Itchy with NDC 67172-502 is a a human over the counter drug product labeled by Prestige Brands Holdings, Inc.. The generic name of Clear Eyes Advanced Dry And Itchy is glycerin. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Prestige Brands Holdings, Inc.

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.


Clear Eyes Advanced Dry And Itchy 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.

  • GLYCERIN 2.5 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.

  • BORIC ACID (UNII: R57ZHV85D4)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • POLIHEXANIDE (UNII: 322U039GMF)
  • PHOSPHATIDYLCHOLINE TRANSLOCATOR ABCB4 (UNII: 9EI49ZU76O)

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: Prestige Brands Holdings, Inc.
Labeler Code: 67172
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: 02-15-2019 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.

Clear Eyes Advanced Dry And Itchy Product Label Images

Clear Eyes Advanced Dry And Itchy 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

Glycerin 0.25%

Purpose

Lubricant

Uses

  • For the temporary relief of burning and irritation due to dryness of the eyefor use as a protectant against further irritation or to relieve dryness of the eye

Warnings

For external use only

Do Not Use

If solution changes color or becomes cloudy

When Using This Product

  • To avoid contamination, do not touch tip to any surfacereplace cap after using

Stop Use And Ask A Doctor If

  • You experience eye painyou experience changes in visionyou experience continued rednes or irritation of the eyethe condition worsenssymptoms last for more than 72 hours

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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

Other Information

  • Store at room temperatureremove contact lenses before using

Inactive Ingredients

Boric acid, phosphatidylcholine, polyhexanide, purified water, sodium borate, sodium chloride, sodium hyaluronate, tocopherol acetate

Questions?

1-877-274-1787 Cleareyes.com

* Please review the disclaimer below.

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