NDC 0363-0191 Walgreens Lubricant Eye Preservative Free

Mineral Oil, White Petrolatum

NDC Product Code 0363-0191

NDC Code: 0363-0191

Proprietary Name: Walgreens Lubricant Eye Preservative Free 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: Mineral Oil, White Petrolatum 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

  • 0363 - Walgreen Company
    • 0363-0191 - Walgreens Lubricant Eye Preservative Free

NDC 0363-0191-50

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

NDC Product Information

Walgreens Lubricant Eye Preservative Free with NDC 0363-0191 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Walgreens Lubricant Eye Preservative Free is mineral oil, white petrolatum. The product's dosage form is ointment and is administered via ophthalmic form.

Labeler Name: Walgreen Company

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.

Walgreens Lubricant Eye Preservative Free 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 425 mg/g
  • PETROLATUM 573 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: Walgreen Company
Labeler Code: 0363
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: 04-01-2019 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.

Walgreens Lubricant Eye Preservative Free 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 Ingredients

Mineral Oil 42.5% and White Petrolatum 57.3%

Purpose

Eye Lubricant

Uses

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

Warnings

• For use in the eyes only.• Retain outer carton for full product drug facts.

When Using This Product

• avoid contamination, do not touch tip of container to any surface.• replace cap after use.

Stop Use And Ask A Doctor If

• you experience eye pain, changes in vision, continued redness or irritation of the eye.• condition worsens or persists for more than 72 hours.

If Pregnant Or Breast Feeding,

Ask a health professional before use.

Keep This And All Drugs Out Of The Reach Of Children.

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

Directions

• pull down lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid, every 3-4 hours or as directed by doctor.

Other Information

• Do not use if bottom ridge of tube cap is exposed. • store at room temperature 15°- 30°C (59°- 86°F).• store away from heat• keep from freezing• see crimp of tube or box for lot number and expiration date.

Inactive Ingredients

Lanolin alcohol

* Please review the disclaimer below.

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