NDC 0536-1217 Rugby Tetrahydrozoline Ophthalmic Solution

Tetrahydrozoline Hcl

NDC Product Code 0536-1217

NDC Code: 0536-1217

Proprietary Name: Rugby Tetrahydrozoline Ophthalmic Solution 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.

Non-Proprietary Name: Tetrahydrozoline Hcl What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 0536 - Rugby Laboratories
    • 0536-1217 - Rugby Tetrahydrozoline Ophthalmic Solution

NDC 0536-1217-94

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

NDC Product Information

Rugby Tetrahydrozoline Ophthalmic Solution with NDC 0536-1217 is a a human over the counter drug product labeled by Rugby Laboratories. The generic name of Rugby Tetrahydrozoline Ophthalmic Solution is tetrahydrozoline hcl. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Rugby Laboratories

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.

Rugby Tetrahydrozoline Ophthalmic Solution 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.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • BORIC ACID (UNII: R57ZHV85D4)
  • WATER (UNII: 059QF0KO0R)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)

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: Rugby Laboratories
Labeler Code: 0536
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: 06-08-2019 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.

Rugby Tetrahydrozoline Ophthalmic Solution Product Label Images

Rugby Tetrahydrozoline Ophthalmic Solution 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 HCI 0.05%

Purpose

Redness Reliever

Use

Relieves redness in 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 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 using

  • Stop use and ask 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

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

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

Directions

Instill 1 to 2 drops in the affected eye(s) up to 4 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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