NDC 62011-0102 Eye Drops Regular

Tetrahydrozoline Hydrochloride

NDC Product Code 62011-0102

NDC 62011-0102-1

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

NDC Product Information

Eye Drops Regular with NDC 62011-0102 is a a human over the counter drug product labeled by Strategic Sourcing Services Llc. The generic name of Eye Drops Regular is tetrahydrozoline hydrochloride. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Strategic Sourcing Services Llc

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

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.

Eye Drops Regular 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 .5 mg/mL

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: Strategic Sourcing Services Llc
Labeler Code: 62011
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: 03-01-2012 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".

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Information for Patients

Tetrahydrozoline Ophthalmic

Tetrahydrozoline Ophthalmic is pronounced as (tet ra hye droz' a leen)

Why is tetrahydrozoline ophthalmic medication prescribed?
Ophthalmic tetrahydrozoline is used to relieve minor eye irritation and redness caused by colds, pollen, and swimming....
[Read More]

* Please review the disclaimer below.

Eye Drops Regular Product Label Images

Eye Drops Regular 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

Tetrahydrozoline HCl 0.05%

Purpose

Tetrahydrozoline HCl - Redness reliever

Keep Out Of Reach Of Children.

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

Uses

  • Relieves redness of the eye due to minor eye irritations

Warnings

  • For external use onlyAsk a doctor before use if you have narrow angle glaucomaWhen using this productpupils may become enlarged temporarilyto avoid contamination, do not touch tip of container to any surface.  Replace cap after using.if solution changes color or becomes cloudy, do not useoveruse may produce increased redness of the eyeremove contact lens before usingStop use and as a doctor if you experienceeye painchanges in visioncontinued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours

Directions

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

Inactive Ingredients

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

Other Information

  • Tamper Evident.  Do not use this product if imprinted neckband is missing or broken.RETAIN THIS CARTON FOR FUTURE REFERENCEStore at 15o - 30oC (59o - 86oF)

* Please review the disclaimer below.