The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Sophia, S.a. De C.v. for the product Splash Tears (NDC 57619-303). 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.
Drug Facts
Manufactured by:
LABORATORIOS SOPHIA, S.A. DE C.V.
Av. Paseo del Norte No. 5255
Guadalajara, Technology Park
Zapopan, Jalisco, Mexico C.P. 45010
Distributed by:
LABS SOPHIA USA, INC.
12941 North Freeway Houston, Suite 225
Houston, Texas, USA 77060
MADE IN MEXICO
Active ingredient
Hypromellose 0.2%
Purpose
Lubricant eye drops
Uses
Temporarily relieves
Warnings
For external use only.
Do not use if solution changes color or becomes cloudy.
When using this product
Stop use and ask a doctor if
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
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
www.sophia.com.mx
NDC 57619-303-01
Splash TEARS®
Dry Eye Relief
Long Lasting
LUBRICANT EYE DROP
HYPROMELLOSE 0.2%
1/2 FL OZ (15 ML)
STERILE
* Please review the disclaimer below.
