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.

Dosage Form: -

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.

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 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. Values = ‘Y’ or ‘N’.

* 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.