Other
Drug Facts
We Fresh Solution/ Drops
FDA Label NDC 62144-0011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oculus Surgical, Inc. for the product We Fresh (NDC 62144-0011). 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 other, active ingredient, purpose, uses, warnings, otc - do not use, when usining this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Glycerin 0.25%
Purpose
Eye lubricant
Uses
For the temporary relief of burning and irritation due to dryness of the eye
For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
For use as a protectant against further irritation or to relieve dryness of the eye.
Warnings
- For external use only
Otc - Do Not Use
- Do not use if solution changes color or becomes cloudy.
- If tamper evident ring is broken or missing.
When Usining This Product
When usining this product
- To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
Otc - Stop Use
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, discontinue use and consult a doctor.
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
Instill 1 or 2 drops in the affected eye(s) as needed.
Other Information
- Store at 15°-25°C (59°-77°F).
Inactive Ingredients
Borate, boric acid, calcium chloride, l-carnitine, sodium chloride, sodium hyaluronate
Principal Display Panel - 10 Ml Bottle Carton
Carton (Otref3393 01 V1 Dx0343 Carton)
Label (241155 Proof Labels)
* Please review the disclaimer below.
