Otc - Active Ingredient
Active ingredient
Propylene Glycol 0.6%
Splash Pure Pf Emulsion
FDA Label NDC 57619-307
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 Pure Pf (NDC 57619-307). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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
Purpose
Eye Lubricant
Indications & Usage
Uses
- for the temporary relief of burning and irritation due to dryness of the eye.
- for use as a protectant against further irritation or to relieve dryness of the eye.
Warnings
Warnings
For external use only
Otc - Do Not Use
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 the nozzle tip to any surface.
- replace cap after each use.
Otc - Stop Use
Stop use and ask a dotor if
- 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.
Dosage & Administration
Directions
- shake well before using.
- instill 1 or 2 eye drops in the affected eye(s) as needed.
Other
Other information
store at room temperature
HYDRATES
REPLENISHES
NDC 57619-307-01
Distributed by:
LABS SOPHIA USA, INC
1790 Hughes Landing Blvd Suite
400, The Woodlands, TX 77380
MADE IN MEXICO
DIRECTIONS
▪ Before first use, squeeze until the first drop is released and discard it.
▪ After each use, shake the bottle to remove any residual liquid from the nozzle tip.
▪ Discard 30 days after opening.
See full instructions inside before use.
TAMPER EVIDENT
Do not use if the tamper evident ring under cap is broken or missing.
Inactive Ingredient
Inactive ingredients
boric acid, castor oil, dimyristoyl phosphatidylcholine (DMPC), disodium edetate dihydrate, glycerin, hyaluronate sodium, polysorbate 80, sodium borate decahydrate, water for injection.
Otc - Questions
Questions?
Call 1-866-282-8871
splasheyedrops.com
Package Label.Principal Display Panel
SOPHIA ®
ADVANCED HYDRATION
Splash ®
Propylene Glycol 0.6%
Lubricant Eye Drops
PURE PF
Dry Eye Relief
Preservative-Free
0.34 FL OZ (10mL) STERILE
* Please review the disclaimer below.
