NDC 73141-001 Lubricating Eye Drops

Carboxymethylcellulose Sodium

NDC Product Code 73141-001

NDC 73141-001-01

Package Description: 8 AMPULE in 1 CARTON > .6 mL in 1 AMPULE

NDC 73141-001-02

Package Description: 32 AMPULE in 1 CARTON > .6 mL in 1 AMPULE

NDC 73141-001-03

Package Description: 52 AMPULE in 1 CARTON > .6 mL in 1 AMPULE

NDC 73141-001-04

Package Description: 72 AMPULE in 1 CARTON > .6 mL in 1 AMPULE

NDC 73141-001-05

Package Description: 100 AMPULE in 1 CARTON > .6 mL in 1 AMPULE

NDC Product Information

Lubricating Eye Drops with NDC 73141-001 is a a human over the counter drug product labeled by A2a Integrated Pharmaceuticals, Llc. The generic name of Lubricating Eye Drops is carboxymethylcellulose sodium. The product's dosage form is liquid and is administered via ophthalmic form.

Labeler Name: A2a Integrated Pharmaceuticals, Llc

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.

Lubricating 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.

  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 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)
  • HYDROCHLORIC ACID (UNII: QTT17582CB)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • 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.
  • 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: A2a Integrated Pharmaceuticals, Llc
Labeler Code: 73141
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: 10-04-2019 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.

Lubricating Eye Drops Product Label Images

Lubricating 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                                                                    Purpose

Carboxymethylcellulose sodium 0.5%------------------------- Eye lubricant

Uses

  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.May be used as a protectant against further irritation of the eye.

Warnings

For external use only• Do not use if solution changes color or becomes cloudy.When using this productto avoid contamination, do no touch tip of container to any surface. Do not reuse. Once open, discard.Do not touch unit dose tip to eye.Stop 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.

Otc - Keep Out Of Reach Of Children

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

Directions

■ TWIST AND REMOVE TAB.■ Place 1 or 2 drops in the affected eye(s) as needed for relief and discard container.■ If used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor’s instructions.

Inactive Ingredients

Calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide*, and sodiumlactate.*May or may not contain this ingredient to adjust pH.

Other Information

■ Use only if single-use container is intact.■ Use before expiration date marked on container.■ RETAIN THIS FOIL FOR FUTURE REFERENCE.

* Please review the disclaimer below.