NDC 73921-009 I-drops Artificial Tears

Hypromellose, Naphazoline Hydrochloride, Polysorbate 80, Zinc Sulfate

NDC Product Code 73921-009

NDC CODE: 73921-009

Proprietary Name: I-drops Artificial Tears 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: Hypromellose, Naphazoline Hydrochloride, Polysorbate 80, Zinc Sulfate 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

  • 73921 - Global Pharma Healthcare Private Limited

NDC 73921-009-15

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

NDC Product Information

I-drops Artificial Tears with NDC 73921-009 is a a human over the counter drug product labeled by Global Pharma Healthcare Private Limited. The generic name of I-drops Artificial Tears is hypromellose, naphazoline hydrochloride, polysorbate 80, zinc sulfate. The product's dosage form is solution/ drops and is administered via ophthalmic form.

Labeler Name: Global Pharma Healthcare Private Limited

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.

I-drops Artificial Tears 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.

  • HYPROMELLOSE, UNSPECIFIED 2 mg/mL
  • NAPHAZOLINE HYDROCHLORIDE .25 mg/mL
  • POLYSORBATE 80 5 mg/mL
  • ZINC SULFATE, UNSPECIFIED FORM 2.5 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.

  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SORBIC ACID (UNII: X045WJ989B)

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: Global Pharma Healthcare Private Limited
Labeler Code: 73921
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: 04-01-2021 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: 12-31-2022 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".

* Please review the disclaimer below.

I-drops Artificial Tears Product Label Images

I-drops Artificial Tears 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

Hypromellose 0.20%Naphazoline Hydrochloride 0.025%Polysorbate 80 0.50%Zinc Sulfate 0.25%

Purpose

LubricantRedness RelieverLubricantLubricant

Uses

• For use as a protectant against further irritation or to relieve dryness of the eye.• For the temporary relief of burning & irritation due to the dryness of the eye.• Relieves redness of the eye due to minor eye irritations.

Warnings

For external use only.Do not use if solution changes color or becomes cloudy.Ask a doctor before use if you have narrow angle glaucomaWhen using this product: • To avoid contamination, do not touch tip of container to any surface. • Replace cap after using. • Overuse of this product may produce increased redness of the eye. • Pupils may become enlarged temporarily.Stop use and ask a doctor if• You experience eye pain• You experience changes in vision• You experience continued redness or irritation of the eye• The condition worsens• Symptoms last for more than 72 hours

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.

Directions

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

Other Information

• Store at room temperature.• Remove contact lenses before using.• Tamper Evident: Do not use if neckband on bottle is broken or missing.

Inactive Ingredients

Calcium chloride, Citric acid, Edetate disodium, Magnesium chloride, Potassium chloride, Purified water, Sodium citrate, Sodium chloride and Sorbic acid.

Questions?

Call toll-free 1-800-572-6632, weekdays, 7:00 AM - 5:30 PM EST.

* Please review the disclaimer below.