ONEDROP- propylene glycol liquid

OneDrop by

Drug Labeling and Warnings

OneDrop by is a Otc medication manufactured, distributed, or labeled by LABORATORIOS SOPHIA, S.A. DE C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Propylene Glycol 0.6%

PURPOSE

Purpose

Lubricant eye drops

INDICATIONS & USAGE

Uses

For the temporary relief of burning and irritation due
to dryness of the eye.

WARNINGS

Warnings

For external use only

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

When using this product

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

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

Keep out of reach of children.

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

DOSAGE & ADMINISTRATION

Directions

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

Other information

Store at room temperature

INACTIVE INGREDIENT

Inactive ingredients

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

QUESTIONS

Questions?

Call +1 (612) 584-9232
www.TearRestore.com
Contact@TearRestore.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

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

Sample box label

INGREDIENTS AND APPEARANCE

ONEDROP 
propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57619-306
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CASTOR OIL (UNII: D5340Y2I9G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM BORATE (UNII: 91MBZ8H3QO)
WATER (UNII: 059QF0KO0R)
DIMYRISTOYLPHOSPHATIDYLCHOLINE, DL- (UNII: U86ZGC74V5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57619-306-01	1 in 1 BOX	08/18/2025
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 57619-306-02	1 in 1 BOX	08/18/2025
2		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	08/18/2025

Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)