Splash Refresh

Splash Refresh
SPL v11
SPL
SPL Set ID 3c1c453e-2644-622a-e063-6394a90a8a94
Route
OPHTHALMIC
Published
Effective Date 2025-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypromellose 2910 (4000 Mpa.s) (0.2 g)
Inactive Ingredients
Benzalkonium Chloride Chondroitin Sulfate (bovine) Edetate Disodium Polysorbate 80 Water Magnesium Chloride Sodium Borate Sodium Chloride Potassium Chloride Boric Acid Chamomile

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-08

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and 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 and Administration

Directions

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

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away 1-800-222-1222.

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.
Section 50567-7

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.
Section 50570-1

Do not use if solution changes color or becomes cloudy.

Section 51727-6

Inactive ingredients

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

Section 51945-4

SOPHIA®

Splash®

SOOTHES

Hypromellose 0.2%

Lubricant Eye Drops

Refresh Your Eyes

CONTAINS CHAMOMILE

Lasting Comfort

0.5 FL OZ (15mL) STERILE

Section 53413-1

Questions?

Call 1-866-282-8871

splasheyedrops.com

Section 55105-1

Purpose

Lubricant eye drops

Section 55106-9

Active ingredient

Hypromellose 0.2%

Other Information
  • store at room temperature
  • do not use if imprinted seal around cap is broken.

Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

Directions

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

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away 1-800-222-1222.

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.
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.
  • remove contact lenses before using.
Section 50570-1 (50570-1)

Do not use if solution changes color or becomes cloudy.

Section 51727-6 (51727-6)

Inactive ingredients

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

Section 51945-4 (51945-4)

SOPHIA®

Splash®

SOOTHES

Hypromellose 0.2%

Lubricant Eye Drops

Refresh Your Eyes

CONTAINS CHAMOMILE

Lasting Comfort

0.5 FL OZ (15mL) STERILE

Section 53413-1 (53413-1)

Questions?

Call 1-866-282-8871

splasheyedrops.com

Section 55105-1 (55105-1)

Purpose

Lubricant eye drops

Section 55106-9 (55106-9)

Active ingredient

Hypromellose 0.2%

Other Information (Other information)
  • store at room temperature
  • do not use if imprinted seal around cap is broken.

Advanced Ingredient Data


Raw Label Data

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