NDC 73921-007 I-drops Lubricant Eye Drops

Glycerin, Hypromellose, Polyethylene Glycol 400

NDC Product Code 73921-007

NDC CODE: 73921-007

Proprietary Name: I-drops Lubricant Eye Drops 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: Glycerin, Hypromellose, Polyethylene Glycol 400 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 73921-007-15

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

NDC Product Information

I-drops Lubricant Eye Drops with NDC 73921-007 is a a human over the counter drug product labeled by Global Pharma Healthcare Private Limited. The generic name of I-drops Lubricant Eye Drops is glycerin, hypromellose, polyethylene glycol 400. 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 Lubricant 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.

  • GLYCERIN 2 mg/mL
  • HYPROMELLOSE, UNSPECIFIED 2 mg/mL
  • POLYETHYLENE GLYCOL 400 10 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.

  • GLYCINE (UNII: TE7660XO1C)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BORIC ACID (UNII: R57ZHV85D4)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BORATE (UNII: 91MBZ8H3QO)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)

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 Lubricant Eye Drops Product Label Images

I-drops Lubricant 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

Glycerin 0.2%Hypromellose 0.2%Polyethylene Glycol 400 1%

Purpose

Lubricant

Uses

• For use as a protectant against further irritation or to relieve dryness of the eye.• For the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun.

Warnings

Do not use this product if solution changes color or becomes cloudyStop use and ask a doctor if you experience• Eye pain, • Changes in vision, • Continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.When using this productTo avoid contamination, do not touch tip of container to any surface.Replace cap after using. Keep container tightly closed.Remove contact lens before using

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 or 2 drops in the affected eye(s) as needed.

Other Information

Do not use if the tamper-resistant bottle cap is broken or opened.RETAIN THIS CARTON FOR FUTURE REFERENCEstore between 15° to 30°C (59°F to 86°F).

Inactive Ingredients

Aminoacetic acid, Ascorbic acid, Benzalkonium chloride, Boric acid, Disodium phosphate, Magnesium chloride, Potassium chloride, Purified water, Sodium borate, Sodium chloride, Sodium citrate, Sodium lactate.

Questions?

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

* Please review the disclaimer below.