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

Active Ingredient

Active ingredient

Propylene Glycol 0.6%

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.

Other Information

Store at room temperature

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

Sample Box Label

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient

Propylene Glycol 0.6%

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.

Other Information (Other information)

Store at room temperature

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

Sample Box Label (Sample box label)

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