NDC 70000-0513 Leader Lubricant Eye

Mineral Oil, And White Petrolatum

NDC Product Code 70000-0513

NDC 70000-0513-1

Package Description: 1 TUBE in 1 BOX > 3.5 g in 1 TUBE

NDC Product Information

Leader Lubricant Eye with NDC 70000-0513 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Lubricant Eye is mineral oil, and white petrolatum. The product's dosage form is ointment and is administered via ophthalmic form.

Labeler Name: Cardinal Health

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Leader Lubricant Eye 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.

  • MINERAL OIL 150 mg/g
  • PETROLATUM 830 mg/g

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.

  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

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: 08-30-2019 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.

Leader Lubricant Eye 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 ingredients PurposeMineral oil 15%........................................................ Eye LubricantWhite petrolatum 83%.............................................. Eye Lubricant

Otc - Purpose

  • UsesFor the temporary relief of burning, irritation, and discomfort due to dryness or the eye or exposure to wind or sun.May be used as a protectant against further irritation

Warnings

  • WarningsFor external use only.To avoid contamination, do not touch tip of container to any surface.Keep tube tightly closed.

Otc - Stop Use

  • Stop use and ask a doctor if:You experience eye pain, changes in vision, continued redness or irritation of the eye. The condition worsens or persists for more than 72 hours. .

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 at 1-800-222-1222.

Indications & Usage

Directions• Wash your hands.

• Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid.

Storage And Handling

  • Other informationstore away from heatprotect from freezinguse before expiration date on the tubestore at 59°-86° (15°-30°)

Inactive Ingredient

Inactive ingredientlanolin alcohol

Dosage & Administration

Directions• Wash your hands.

• Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid.

* Please review the disclaimer below.