Splash Refresh .2 g/100mL

Hypromellose · SOLUTION/ DROPS · LABORATORIOS SOPHIA, S.A. DE C.V.

No Recall History

Plain English

Splash Refresh is a solution/ drops containing hypromellose at .2 g/100mL, taken ophthalmic. Manufactured by LABORATORIOS SOPHIA, S.A. DE C.V..

Key Facts

Brand Name: Splash Refresh
Generic Name: Hypromellose
NDC Code (Product): 57619-305
Manufacturer: LABORATORIOS SOPHIA, S.A. DE C.V.
Strength: .2 g/100mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: M018
Marketing Start: 08/08/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

dyspnoea77 reports

nausea75 reports

dizziness73 reports

confusional state71 reports

vomiting70 reports

headache68 reports

diarrhoea67 reports

hyponatraemia58 reports

malaise57 reports

abdominal pain54 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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.

Dosage & Administration

Directions instill 1 or 2 drops in the affected eye(s) as needed

Warnings

Warnings For external use only. Do not use if solution changes color or becomes cloudy. 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. 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away 1-800-222-1222.

Frequently Asked Questions

What is Splash Refresh used for?

Splash Refresh contains Hypromellose. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Splash Refresh a controlled substance?

Splash Refresh is not classified as a controlled substance by the DEA.

What is the generic name for Splash Refresh?

The generic name for Splash Refresh is Hypromellose. There are 11 other brand versions of Hypromellose.

What is the NDC code for Splash Refresh .2 g/100mL?

The NDC (National Drug Code) for Splash Refresh .2 g/100mL is 57619-305, listed by LABORATORIOS SOPHIA, S.A. DE C.V..

Product NDC

57619-305

Package NDC

57619-305-01

Other Hypromellose Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)