Otc - Active Ingredient
Active ingredients Purposes
Polyethylene glycol 400 0.4%........................................Eye lubricant
Propylene glycol 0.3%...................................................Eye lubricant
Goodsense Lubricant Eye
FDA Label NDC 50804-665
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 Lubricant Eye (NDC 50804-665). 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 - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use
- 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 the solution 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
- do not reuse
- once opened, discard
- remove contact lenses before using
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) lasts
- condition worsens 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 reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Indications & Usage
Directions
- to open, twist and pull tab to remove
- instill 1 or 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 20-25°C (68-77°F)
- protect from light
Inactive Ingredient
Inactive ingredients
aminomethylpropanol, boric acid, hydrochlorid acid, hydroxyethyl cellulose, potassium chloride, purified water, sodium chloride, sodium hydroxide, sorbitol
Dosage & Administration
Distributed by:
Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
www.valuelabels.com
Made in South Korea
Package Label.Principal Display Panel
89665 (89665)
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