NDC 0536-1218 Rugby Polyvinyl Alcohol Lubricating Eye Drops

Polyvinyl Alcohol

NDC Product Code 0536-1218

NDC Code: 0536-1218

Proprietary Name: Rugby Polyvinyl Alcohol Lubricating Eye Drops 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: Polyvinyl Alcohol 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

  • 0536 - Rugby Laboratories
    • 0536-1218 - Rugby Polyvinyl Alcohol Lubricating Eye Drops

NDC 0536-1218-94

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

NDC Product Information

Rugby Polyvinyl Alcohol Lubricating Eye Drops with NDC 0536-1218 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Rugby Polyvinyl Alcohol Lubricating Eye Drops is polyvinyl alcohol. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Rugby Laboratories

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.

Rugby Polyvinyl Alcohol Lubricating Eye Drops 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.

  • POLYVINYL ALCOHOL 1.4 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.

  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)

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: Rugby Laboratories
Labeler Code: 0536
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: 07-25-2019 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.

Rugby Polyvinyl Alcohol Lubricating Eye Drops Product Label Images

Rugby Polyvinyl Alcohol Lubricating Eye Drops 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 1.4%

Otc - Purpose

​PurposePolyvinyl alcohol: Lubricant

Indications & Usage

  • Uses: for use as a protectant against further irritation or to relieve dryness of the eyefor the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

Warnings For external use only

Otc - Do Not Use

  • Do not use this product if solution changes color or becomes cloudy

Otc - When Using

  • When using this productremove contact lens before usingto avoid contamination, do not touch tip of container to any surfacereplace cap after using. Keep container tightly closed

Otc - Stop Use

  • Stop use and ask a doctor if you experienceeye painchanges in visioncontinued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Dosage & Administration

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

Other Safety Information

  • Other informationStore at room temperature

Inactive Ingredient

Inactive ingredientsbenzalkonium chloride (preservative), disodium edetate, purified water, sodium chloride, sodium phosphate dibasic, and sodium phosphate monobasic

Otc - Questions

Questions or comments? call 1-800-645-2158

* Please review the disclaimer below.

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