NDC 54799-917 Retaine Mgd

Mineral Oil

NDC Product Code 54799-917

NDC 54799-917-30

Package Description: 30 VIAL, SINGLE-DOSE in 1 CONTAINER > .4 mL in 1 VIAL, SINGLE-DOSE

NDC Product Information

Retaine Mgd with NDC 54799-917 is a a human over the counter drug product labeled by Ocusoft, Inc.. The generic name of Retaine Mgd is mineral oil. The product's dosage form is emulsion and is administered via ophthalmic form.

Labeler Name: Ocusoft, Inc.

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Retaine Mgd 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.

  • LIGHT MINERAL OIL 2 mg/.4mL
  • MINERAL OIL 2 mg/.4mL

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.

  • CETALKONIUM CHLORIDE (UNII: 85474O1N9D)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLOXAMER 188 (UNII: LQA7B6G8JG)
  • TROMETHAMINE HYDROCHLORIDE (UNII: 383V75M34E)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • TYLOXAPOL (UNII: Y27PUL9H56)
  • WATER (UNII: 059QF0KO0R)

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: Ocusoft, Inc.
Labeler Code: 54799
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: 01-05-2012 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: 12-31-2021 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 - NO 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.

Retaine Mgd 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

Light Mineral Oil (0.5)................................EmollientMineral Oil (0.5%).....................................Emollient

Uses

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

Warnings

For use in the eyes only.

Do Not Use

  • If this product changes color.

When Using This Product

  • Do not touch tip of container to any surface to avoid contamination.do not reuse once opened.

Stop Use And Ask A Doctor If

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

Keep Out Of The Reach Of Children

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

Directions

  • Shake well before using.Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

Other Information

  • Use only if printed tamper seals on top and bottom flaps are intact.Drops appear as a milky white solution.Store between 15
  • O-30
  • OC (59
  • O-86
  • OF).

Inactive Ingredients

Cetalkonium chloride, glycerol, poloxamer 188, tris hydrochloride, tromethamine, tyloxapol, water for injection.

Questions?

Call (800)233-5469 M-F 8:30AM-5:00PM CST or visit www.retainebrand.com

Otc - Purpose

Emollient

* Please review the disclaimer below.