Splash Redness Reliever

SPL v4

SPL

SPL Set ID fa4140e6-dc80-da99-e053-6294a90a194f

Route

OPHTHALMIC

Published

Effective Date 2025-05-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hypromellose 2910 (4000 Mpa.s) (0.2 g) Naphazoline (0.02 g)

Inactive Ingredients

Sodium Borate Polysorbate 80 Chondroitin Sulfate (bovine) Magnesium Chloride Water Potassium Chloride Sodium Chloride Edetate Disodium Benzalkonium Chloride Boric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-04-25

Description

Active ingredient . . . . . . . . . . . . . . . . Purpose Hypromellose 0.2%............................Lubricant Naphazoline hydrochloride 0.02%.....Redness reliever

Medication Information

Description

Active ingredient . . . . . . . . . . . . . . . . Purpose Hypromellose 0.2%............................Lubricant Naphazoline hydrochloride 0.02%.....Redness reliever

Uses

Temporarily relieves

redness due to minor eye irritation
protection against further irritation
burning and irritation due to dryness of the eye

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contat a Poison Control Center right away

Section 50566-9

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

Section 50567-7

When using this product

do not touch tip of container to any surface to avoid contamination.
replace cap after using.

Section 50569-3

ask a doctor before use if you have narrow angle glaucoma.

Section 50570-1

Do not use

if solution changes color or becomes cloudy.

Section 51945-4

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

Section 55105-1

Purpose

Section 55106-9

Active ingredient . . . . . . . . . . . . . . . . Purpose

Hypromellose 0.2%............................Lubricant

Naphazoline hydrochloride 0.02%.....Redness reliever

Warnings

For external use only.

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

Questions?

Call 1-866-282-8871

splashtears.com

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.

Structured Label Content

Uses

Temporarily relieves

redness due to minor eye irritation
protection against further irritation
burning and irritation due to dryness of the eye

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contat a Poison Control Center right away

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

do not touch tip of container to any surface to avoid contamination.
replace cap after using.

Section 50569-3 (50569-3)

ask a doctor before use if you have narrow angle glaucoma.

Section 50570-1 (50570-1)

Do not use

if solution changes color or becomes cloudy.

Section 51945-4 (51945-4)

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

Section 55105-1 (55105-1)

Purpose

Section 55106-9 (55106-9)

Active ingredient . . . . . . . . . . . . . . . . Purpose

Hypromellose 0.2%............................Lubricant

Naphazoline hydrochloride 0.02%.....Redness reliever

Warnings

For external use only.

Directions

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.

Questions?

Call 1-866-282-8871

splashtears.com

Other Information (Other information)

store at room temperature
do not use if imprinted seal around cap is broken
remove contact lenses before using

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, chondroitin sulfate, edetate disodium, magnesium chloride, polysorbate 80, potassium chloride, sodium borate, sodium chloride, water for injection.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves redness due to minor eye irritation protection against further irritation burning and irritation due to dryness of the eye", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contat a Poison Control Center right away", "50566-9": "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", "50567-7": "When using this product do not touch tip of container to any surface to avoid contamination. replace cap after using.", "50569-3": "ask a doctor before use if you have narrow angle glaucoma.", "50570-1": "Do not use if solution changes color or becomes cloudy.", "51945-4": "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", "55105-1": "Purpose", "55106-9": "Active ingredient . . . . . . . . . . . . . . . . Purpose Hypromellose 0.2%............................Lubricant Naphazoline hydrochloride 0.02%.....Redness reliever", "Warnings": "For external use only.", "Directions": "Instill 1 or 2 drops in the affected eye(s) up to 4 times daily.", "Questions?": "Call 1-866-282-8871 splashtears.com", "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:09.341612 · Updated: 2026-03-14T23:08:46.104923