NDC 70000-0454 Leader Original Eye Drops

Tetrahydrozoline Hcl

NDC Product Code 70000-0454

NDC 70000-0454-1

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

NDC Product Information

Leader Original Eye Drops with NDC 70000-0454 is a a human over the counter drug product labeled by Cardinal Health. The generic name of Leader Original Eye Drops is tetrahydrozoline hcl. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: Cardinal Health

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Leader Original Eye Drops 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.

  • TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL

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 BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

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: Cardinal Health
Labeler Code: 70000
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: 02-19-2019 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: 12-31-2020 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 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 Original Eye Drops Product Label Images

Leader Original 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

Active Ingredient

Tetrahydrozoline HCL 0.05%

Purpose

Redness reliever

Uses

  • Relieves redness of the eye due to minor eye irritations

Warnings

For external use only

Ask A Doctor Before Use If You Have

Narrow angle glaucoma

When Using This Product

  • Pupils may become enlarged temporarilyto avoid contamination, do not touch tip of container to any surface. Replace cap after usingif solution changes color or becomes cloudy, do not useoveruse may produce increased redness of the eyeremove contact lens before using

Stop Use And Ask A Doctor If

  • You experience eye painchanges in visioncontinued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours

If Pregnant Or Breast-Feeding

Ask a health professional before use

Keep Out Of Reach Of Chlidren

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily

Other Information

Store at 15-30°C (59°-86°F)

Inactive Ingredients

Benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

* Please review the disclaimer below.

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