Gnp Lubricant Eye
FDA Label NDC 46122-018

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amerisource Bergen for the product Gnp Lubricant Eye (NDC 46122-018). 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 - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients                                                              Purpose

Polyethylene Glycol 400 (0.4%).........................................Lubricant

Propylene Glycol (0.3%)....................................................Lubricant

Otc - Purpose

Uses

  • For the temporary relief of burning and irritation due to dryness of the eye.

Warnings

Warnings For external use only.

Otc - Do Not Use

Do not use

  • if this product changes color or becomes cloudy.
  • if you are sensitive to any ingredient in this product.

Otc - When Using

When using this product

  • 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(s) get worse or lasts 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.

Indications & Usage

Directions

  • Instill 1 to 2 drops in the affected eye(s) as needed
  • Children under 6 years of age: Ask a doctor.

Storage And Handling

Other information

  • Store at room temperature.
  • Do not use if carton is open or neckband on the bottle is broken or missing.

Inactive Ingredient

Inactive ingredients: Boric Avid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hypromellose 2910, Magnesium Chloride, Potassium Chloride, Purified Water, Sodim Chloride, Sodium Hydroxide, Zinc Chloride

Dosage & Administration

Distributed By:

Amerisource Bergen Corporation

1300 Morris Drive

Chesterbrook, PA 19087  

Made in Korea

Package Label.Principal Display Panel

Image Of Carton Label (Gnplubricanteyedrops)

Image Of Carton Label (Gnplubricanteyedrops)

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