Goodsense Artificial Tears Solution
FDA Label NDC 63187-298

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Goodsense Artificial Tears (NDC 63187-298). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Uses

  • temporary relieves burning and irritations due to dryness of the eye(s)
  • protects against further irritation

Warnings

Warnings

For external use only.  Do not use if solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

Otc - When Using

When using this product

  • remove contact lenses before using
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Otc - Stop Use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye gets worse or lasts more than 72 hours

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding,

ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

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

Indications & Usage

Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Store at 15-25C (59-77F).
  • Children under 6 years of age: Ask a doctor

Dosage And Administration

  • Instill 1 or 2 drops in the affected eye(s) as needed.

Active Ingredient

Each mL contains: Polyvinyl Alcohol 5mg/ml and Povidone 6mg/ml - lubricant

Inactive Ingredient

Inactive Ingredients: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Sodium Phosphate (Mono- and Dibasic)

Package Label.Principal Display Panel

63187-298-15 (Image 01)

63187-298-15 (Image 01)

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

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