NDC 11716-9638 Leader Relief

NDC Product Code 11716-9638

NDC 11716-9638-3

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 Relief with NDC 11716-9638 is a product labeled by Hanlim Pharm. Co., Ltd.. The generic name of Leader Relief is . The product's dosage form is and is administered via form.

Labeler Name: Hanlim Pharm. Co., Ltd.

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 CITRATE (UNII: 1Q73Q2JULR)

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: 10-08-2010 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 Relief Product Label Images

Leader Relief 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                                                                            PurposeTetrahydrozoline HCL 0.05% ...........................................................Redness RelieverZinc Sulfate 0.25% .........................................................................Astringent

Otc - Purpose

  • Usesfor the temporary relief of redness and irritation of the eye and for use as a protectant against further irritation.for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun.

Warnings

WarningsFor external use only.

Otc - Do Not Use

Do not use: If this solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

Otc - When Using

  • When using this productremove contact lenses before usingdo 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 occur redness or irritation of eye gets worse 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

  • Directionsinstill 1 or 2 drops in the affected eye(s) up to 4 times daily.Store at room temperature.Children under 6 years of age: Ask a doctor

Inactive Ingredient

Inactive Ingredients: Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Chloride, Sodium Citrate

Dosage & Administration

Distributed By Cardinal HealthDublin, OH 43017CIN 1963735www.myleader.com1-800-200-6313

* Please review the disclaimer below.