NDC 0536-1383 Mineral Oil With Petroleum
Mineral Oil And White Petrolatum Ointment Ophthalmic

Product Information

What is NDC 0536-1383?

The NDC code 0536-1383 is assigned by the FDA to the product Mineral Oil With Petroleum which is a human over the counter drug product labeled by Rugby Laboratories. The generic name of Mineral Oil With Petroleum is mineral oil and white petrolatum. The product's dosage form is ointment and is administered via ophthalmic form. The product is distributed in a single package with assigned NDC code 0536-1383-91 1 tube in 1 carton / 3.5 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0536-1383
Proprietary Name 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.		Mineral Oil With Petroleum
Non-Proprietary Name 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.		Mineral Oil And White Petrolatum
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Mineral Oil; Petrolatum
Product Type 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.		Human Otc Drug
Dosage FormOintment - 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.
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.		Rugby Laboratories
Labeler Code0536
FDA Application Number 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.		part349
Marketing Category 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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		02-27-2023
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Mineral Oil With Petroleum?


Product Packages

NDC Code 0536-1383-91

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

Product Details

What are Mineral Oil With Petroleum Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • MINERAL OIL 30 mg/g - A mixture of liquid hydrocarbons obtained from petroleum. It is used as laxative, lubricant, ointment base, and emollient.
  • PETROLATUM 940 mg/g - A colloidal system of semisolid hydrocarbons obtained from PETROLEUM. It is used as an ointment base, topical protectant, and lubricant.

Mineral Oil With Petroleum Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 706820 - mineral oil 3 % / petrolatum 94 % Ophthalmic Ointment
  • RxCUI: 706820 - mineral oil 0.03 MG/MG / petrolatum 0.94 MG/MG Ophthalmic Ointment
  • RxCUI: 706820 - mineral oil 3 % / petrolatum, white 94 % Ophthalmic Ointment

Mineral Oil With Petroleum Inactive Ingredients UNII Codes

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.

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Mineral Oil With Petroleum Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Otc - Purpose



Active ingredientsPurpose
Mineral Oil 3%Lubricant
White Petrolatum 94%Lubricant

Uses



  • For temporary relief of irritation or dryness in the eye.

Warnings



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

Do not use if: • you are sensitive to any ingredient in this product.

Do not use if bottom ridge of tube is exposed, or if cap of tube is damaged.


Stop Use



Stop use and ask a doctor if you are experiencing any of the following:

• You experience eye pain or change in vision, continued dryness or irritation of the eye. • The condition worsens. • Symptoms last longer 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 (1-800-222-1222).


Directions



• Wash your hands. • Pull down lower lid of the affected eye and apply a small amount (1/4” 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° to 30° C (59° to 86°F) • Keep tube tightly closed. • See crimp of tube or box for lot number and expiration date.

Inactive Ingredient



Lanolin alcohol.


Otc - Questions



Questions or Comments? • 888-969-6855


Principal Display Panel



Carton - 7223308 CAH RGB Systane PM LubricantEyeOintment BOX r3 F

Carton - 7223308 CAH RGB Systane PM LubricantEyeOintment BOX r3 F


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