NDC 11716-1104 Leader Advanced Formula Eye Drops

  1. Labeler Index
  2. Hanlim Pharm. Co., Ltd.
  3. NDC: 11716-1104 Leader Advanced Formula Eye Drops

NDC Product Code 11716-1104

NDC CODE: 11716-1104

Proprietary Name: Leader Advanced Formula Eye Drops 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.
  • This product is used as
    • usesfor the relief of redness of the eyes due to minor eye irritationsfor use as a protectant against further irritation or to relieve dryness of the eye

NDC Code Structure

NDC 11716-1104-1

Package Description: 1 BOTTLE in 1 CARTON > 15 mL in 1 BOTTLE

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

NDC Product Information

Leader Advanced Formula Eye Drops with NDC 11716-1104 is product labeled by Hanlim Pharm. Co., Ltd.. The product's dosage form is and is administered via form.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)

Product Labeler Information

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

Labeler Name: Hanlim Pharm. Co., Ltd.
Labeler Code: 11716
Start Marketing Date: 05-06-2010 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: 12-31-2018 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.

Leader Advanced Formula Eye Drops Product Label Images

Leader Advanced Formula Eye Drops 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                                                                PurposeDextran 70 0.1%.................................................................LubricantPolyethylene glycol 400 1%.................................................LubricantPovidone 1%......................................................................LubricantTetrahydrozoline HCL 0.05%................................................Redness reliever

Otc - Purpose

  • Usesfor the relief of redness of the eyes due to minor eye irritationsfor use as a protectant against further irritation or to relieve dryness of the eye

Warnings

WarningsAsk a doctor before use if you have narrow angle glaucoma

Otc - When Using

  • When using this productpupils may become enlarged temporarilyoveruse may cause more eye rednessremove contact lenses before usingdo not use if this solution changes color or becomes cloudydo not touch tip of container to any surface to avoid contaminationreplace cap after each use

Otc - Stop Use

  • Stop use and ask a doctor if you feel eye painchanges in vision occurredness or irritation of the eye lastscondition worsens or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

  • Directionsput 1 to 2 drops in the affected eye(s) up to 4 times dailychildren under 6 years of age: ask a doctor

Storage And Handling

Other informationsome users may experience a brief tingling sensationstore at 15o to 25oC (59o to 77oF)

Inactive Ingredient

Inactive ingredients:benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, and sodium borate

* Please review the disclaimer below.