NDC 21695-681 Mineral Oil

NDC Product Code 21695-681

NDC CODE: 21695-681

Proprietary Name: Mineral Oil 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Mineral oil is used to treat constipation. It is known as a lubricant laxative. It works by keeping water in the stool and intestines. This helps to soften the stool and also makes it easier for stool to pass through the intestines. This medication should not be used in older adults, children younger than 6 years, or in people who are bedridden.

NDC Code Structure

NDC 21695-681-07

Package Description: 7 g in 1 TUBE

NDC 21695-681-35

Package Description: 3.5 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Mineral Oil with NDC 21695-681 is a product labeled by Rebel Distributors Corp. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 701984.

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.

  • CHLOROBUTANOL (UNII: HM4YQM8WRC)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rebel Distributors Corp
Labeler Code: 21695
Start Marketing Date: 11-30-2007 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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".

* Please review the disclaimer below.

Mineral Oil 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 Ingredient

Mineral Oil 42.5%White Petrolatum 56.8%

Purpose

Eye lubricant

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

For use as a protectant against further irritation or to relieve dryness or the eye.

Warnings

For external use only.To avoid contamination, do not touch tip of container to any surface.Replace cap after using.Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Directions

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other Information

Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.Store away from heat. Protect from freezing.Use before expiration date marked on container.RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

Chlorobutanol and lanolin alcohols.

* Please review the disclaimer below.