Otc - Active Ingredient
Active ingredient . . . . . . . . . . . . . . . .
Purpose
Hypromellose 0.2%............................Lubricant
Naphazoline hydrochloride 0.02%.....Redness reliever
Splash Redness Reliever Solution/ Drops
FDA Label NDC 57619-304
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 Redness Reliever (NDC 57619-304). 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, uses, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
Temporarily relieves
- redness due to minor eye irritation
- protection against further irritation
- burning and irritation due to dryness of the eye
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.
Otc - Ask Doctor
ask a doctor before use if you have narrow angle glaucoma.
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.
- overuse may cause more redness of the eye
- pupil may become enlarged temporarily
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contat a Poison Control Center right away
Directions
Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
Other Information
- store at room temperature
- do not use if imprinted seal around cap is broken
- remove contact lenses before using
Inactive Ingredients
benzalkonium chloride, boric acid, chondroitin sulfate, decahydrate edetate disodium, magnesium chloride hexahydrate, polysorbate 80, potassium chloride, sodium borate, sodium chloride, water for injection.
Questions?
Call 1-866-282-8871
splashtears.com
Package Label.Principal Display Panel
Splash
®
Redness Reliever
Lubricant redness reliever Eye drops
Fast-Acting Reliever
0.5 FL OZ (15 mL)
Relieves REDNESS BURNING IRRITATION
Sophia
®
Distributed by:
LABS SOPHIA USA, INC
1790 Hughes Landing Blvd, Suite 400
The Woodlands, TX 77380
MADE IN MEXICO
* Please review the disclaimer below.
