Indications and uses
Temporarily relieves redness due to minor eye irritation protection against further irritation burning and irritation due to dryness of the eye
Splash Redness Reliever
- Manufacturer
- LABORATORIOS SOPHIA, S.A. DE C.V.
- Effective date
- 2025-05-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:01:16
Label at a glance#
ProductSplash Redness Reliever
Active ingredientHYPROMELLOSE 2910 (4000 MPA.S), NAPHAZOLINE HYDROCHLORIDE
Label structure9 sections
Dosage and administration
Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.
Storage and handling
store at room temperature do not use if imprinted seal around cap is broken remove contact lenses before using
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient . . . . . . . . . . . . . . . .
Purpose
Hypromellose 0.2%............................Lubricant
Naphazoline hydrochloride 0.02%.....Redness reliever
OTC - PURPOSE SECTION
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 SECTION
Do not use
if solution changes color or becomes cloudy.
OTC - WHEN USING SECTION
When using this product
- do not touch tip of container to any surface to avoid contamination.
- replace cap after using.
OTC - ASK DOCTOR SECTION
ask a doctor before use if you have narrow angle glaucoma.
OTC - STOP USE SECTION
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 SECTION
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, edetate disodium, magnesium chloride, polysorbate 80, potassium chloride, sodium borate, sodium chloride, water for injection.
Questions?
Call 1-866-282-8871
splashtears.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Sophia ®
REDNESS RELIEVER
Splash
®
Lubricant
Redness Reliever Eye Drops
Red Eye Relief
Fast-Acting Reliever
0.5 FL OZ (15 mL)
STERILE
RELIEVES REDNESS BURNING IRRITATION
NDC 57619-304-01
Distributed by:
LABS SOPHIA USA, INC
1790 Hughes Landing Blvd, Suite 400
The Woodlands, TX 77380
MADE IN MEXICO
splashtears.com
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2636530 | hypromellose 0.2 % / naphazoline HCl 0.02 % Ophthalmic Solution | PSN | 4 |
| 2636530 | hypromellose 2 MG/ML / naphazoline hydrochloride 0.2 MG/ML Ophthalmic Solution | SCD | 4 |
| 2636530 | hypromellose 0.2 % / naphazoline hydrochloride 0.02 % Ophthalmic Solution | SY | 4 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57619-304-01 | Splash Redness Reliever | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 4 | |
| 57619-304-01 | Splash Redness Reliever | 15 mL in 1 BOTTLE, PLASTIC | SOLUTION/ DROPS | 15 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Splash Redness Reliever
- Hypromellose, Naphazoline hydrochloride
- SODIUM BORATE
- POLYSORBATE 80
- CHONDROITIN SULFATE (BOVINE)
- HYPROMELLOSE 2910 (4000 MPA.S)
- NAPHAZOLINE HYDROCHLORIDE
- NAPHAZOLINE
- MAGNESIUM CHLORIDE
- WATER
- POTASSIUM CHLORIDE
- SODIUM CHLORIDE
- EDETATE DISODIUM
- BENZALKONIUM CHLORIDE
- BORIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57619-304 | 57619-304-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM BORATE | 91MBZ8H3QO | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| CHONDROITIN SULFATE (BOVINE) | 6IC1M3OG5Z | IACT |
| HYPROMELLOSE 2910 (4000 MPA.S) | RN3152OP35 | ACTIB |
| NAPHAZOLINE HYDROCHLORIDE | MZ1131787D | ACTIB |
| MAGNESIUM CHLORIDE | 02F3473H9O | IACT |
| WATER | 059QF0KO0R | IACT |
| POTASSIUM CHLORIDE | 660YQ98I10 | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| BORIC ACID | R57ZHV85D4 | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Splash Redness Reliever | HYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDE | LABORATORIOS SOPHIA, S.A. DE C.V. | fa4140e6-dc80-da99-e053-6294a90a194f | 2025-05-09 | Warnings | 57619-304-01 57619-304 57619030401 351e11b7-7c46-9bc7-e063-6294a90a46a7 fa4140e6-dc80-da99-e053-6294a90a194f |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.