Tear Restore One Drop

Tear Restore One Drop
SPL v1
SPL
SPL Set ID 3cb9857f-529b-ad6c-e063-6294a90aa418
Route
OPHTHALMIC
Published
Effective Date 2025-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Propylene Glycol (0.6 g)
Inactive Ingredients
Boric Acid Polysorbate 80 Castor Oil Edetate Disodium Glycerin Hyaluronate Sodium Sodium Borate Water Dimyristoylphosphatidylcholine, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-18
Description

Active ingredient Propylene Glycol 0.6%

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the temporary relief of burning and irritation due

to dryness of the eye.

Dosage and Administration

Directions

  • Shaking is not required
  • Instill 1 or 2 drops in the affected eye(s) as needed.

Description

Active ingredient Propylene Glycol 0.6%

Section 42229-5

For external use only. See Drug Facs for complete directions and safety information.

NDC: 57619-306-01

Distributed By

TearRestore Inc.

Arden Hills, MN 55112 USA

Country of Origin Mexico

www.TearRestore.com

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if you experience any of the following:

  • 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

  • Make sure the tip of container does not touch any surface to avoid contamination.
  • Replace cap after each use
Section 50570-1

Do not use

  • If this product changes color or becomes cloudy
  • If you are sensitive to any ingredient in this product.
  • Do not use if imprinted seal around cap is broken or bottle is damaged
Section 51727-6

Inactive ingredients

Boric acid, castor oil, dimyristoyl phosphatidylcholine (DMPC), disodium edetate dihydrate, glycerin,hyaluronate sodium, polysorbate 80, sodium borate decahydrate, water for injection.

Section 51945-4

TearRestore

OneDrop

PRESERVATIVE FREE

Lubricant Eye Drops

Hyaluronic Acid

Safe with Contacts

Blur-Free Formulation

Propylene Glycol 0.6%

10mL / 0.34 Fl. Oz. Bottle

Section 53413-1

Questions?

Call +1 (612) 584-9232

www.TearRestore.com

[email protected]

Section 55105-1

Purpose

Lubricant eye drops

Section 55106-9

Active ingredient

Propylene Glycol 0.6%

Sample Box Label

Other Information

Store at room temperature

Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of burning and irritation due

to dryness of the eye.

Dosage and Administration (34068-7)

Directions

  • Shaking is not required
  • 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)

For external use only. See Drug Facs for complete directions and safety information.

NDC: 57619-306-01

Distributed By

TearRestore Inc.

Arden Hills, MN 55112 USA

Country of Origin Mexico

www.TearRestore.com

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience any of the following:

  • 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

  • Make sure the tip of container does not touch any surface to avoid contamination.
  • Replace cap after each use
Section 50570-1 (50570-1)

Do not use

  • If this product changes color or becomes cloudy
  • If you are sensitive to any ingredient in this product.
  • Do not use if imprinted seal around cap is broken or bottle is damaged
Section 51727-6 (51727-6)

Inactive ingredients

Boric acid, castor oil, dimyristoyl phosphatidylcholine (DMPC), disodium edetate dihydrate, glycerin,hyaluronate sodium, polysorbate 80, sodium borate decahydrate, water for injection.

Section 51945-4 (51945-4)

TearRestore

OneDrop

PRESERVATIVE FREE

Lubricant Eye Drops

Hyaluronic Acid

Safe with Contacts

Blur-Free Formulation

Propylene Glycol 0.6%

10mL / 0.34 Fl. Oz. Bottle

Section 53413-1 (53413-1)

Questions?

Call +1 (612) 584-9232

www.TearRestore.com

[email protected]

Section 55105-1 (55105-1)

Purpose

Lubricant eye drops

Section 55106-9 (55106-9)

Active ingredient

Propylene Glycol 0.6%

Sample Box Label (Sample box label)

Other Information (Other information)

Store at room temperature

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:50.494708 · Updated: 2026-03-14T23:09:50.407692