Other
Drug Facts
NDC 57619-305-01
Distributed by:
LABS SOPHIA USA, INC.
1790 Hughes Landing Blvd Suite 400
The Woodlands, TX 77380
MADE IN MEXICO
splasheyedrops.com
Splash Refresh Solution/ Drops
FDA Label NDC 57619-305
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Sophia, S.a. De C.v. for the product Splash Refresh (NDC 57619-305). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Hypromellose 0.2%
Otc - Purpose
Purpose
Lubricant eye drops
Indications & Usage
Uses
Temporarily relieves
- burning and irritation due to dryness of the eye.
- discomfort due to minor irritations of the eye or to exposure to wind or sun.
Warnings
Warnings
For external use only.
Otc - Do Not Use
Do not use if solution changes color or becomes cloudy.
Otc - When Using
When using this product
- do not touch tip of container to any surface to avoid contamination.
- replace cap after using.
- remove contact lenses before 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.
- condition worsens or persists for 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 1-800-222-1222.
Dosage & Administration
Directions
instill 1 or 2 drops in the affected eye(s) as needed
Other Information
- store at room temperature
- do not use if imprinted seal around cap is broken.
Inactive Ingredient
Inactive ingredients
benzalkonium chloride, boric acid, chamomile, chondroitin sulfate sodium, edetate disodium dihydrate, magnesium chloride hexahydrate, polysorbate 80, potassium chloride, sodium borate decahydrate, sodium chloride, water for injection.
Otc - Questions
Questions?
Call 1-866-282-8871
splasheyedrops.com
Package Label.Principal Display Panel
SOPHIA®
Splash®
SOOTHES
Hypromellose 0.2%
Lubricant Eye Drops
Refresh Your Eyes
CONTAINS CHAMOMILE
Lasting Comfort
0.5 FL OZ (15mL) STERILE
* Please review the disclaimer below.
