NDC 70000-0013 Restorative Formula Lubricant Eye Drops

Propylene Glycol

NDC Product Code 70000-0013

NDC 70000-0013-1

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

NDC 70000-0013-2

Package Description: 2 BOTTLE, DROPPER in 1 BOX > 15 mL in 1 BOTTLE, DROPPER

NDC Product Information

Restorative Formula Lubricant Eye Drops with NDC 70000-0013 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Restorative Formula Lubricant Eye Drops is propylene glycol. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Cardinal Health

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.


Restorative Formula Lubricant 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.

  • PROPYLENE GLYCOL .6 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)
  • BORIC ACID (UNII: R57ZHV85D4)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: Cardinal Health
Labeler Code: 70000
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: 04-30-2019 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.

Restorative Formula Lubricant Eye Drops Product Label Images

Restorative Formula Lubricant 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 ingredientsPropylene glycol....0.6%

Otc - Purpose

PurposePropylene glycol............ Lubricant

Indications & Usage

Uses• for the temporary relief of burning and irritation due to dryness of the eye

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use• if this product changes color• if you are sensitive to any ingredient in this product

Otc - When Using

When using this product• do not touch tip of container to any surface to avoid contamination• replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if• you experience eye pain• changes in vision occur• redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Dosage & Administration

  • DirectionsShake well before using.Instill 1 or 2 drops in the affected eye(s) as needed

Other Safety Information

  • Other informationStore at room temperature.

Inactive Ingredient

Inactive ingredientsBenzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Otc - Questions

Questions & comments?1-888-527-4276

* Please review the disclaimer below.

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