Goodsense Ultra Lubricant
FDA Label NDC 50804-821

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc for the product Goodsense Ultra Lubricant (NDC 50804-821). 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 - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients                              Purpose

Polyethlene glycol 400 0.4%.............Eye lubricant

Propylene glycol 0.3%.......................Eye lubricant

Otc - Purpose

Uses

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

Warnings

Warnings

For external use only

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 containation
  • 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) gets worse, persists 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

  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed

Storage And Handling

Other information

  • store at room temperature

Inactive Ingredient

Inactive ingredients

boric acid, calcium chloride, chlorhexidine gluconate, hydrochloric acid, hypromellose, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide, zinc chloride

Dosage & Administration

Distributed By:

Geiss, Destin & Dunn, Inc.

Peachtree City, GA 30269

www.valuelabels.com

1-866-696-0957

Made in Korea

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