Otc - Active Ingredient
Active ingredient
Propylene Glycol 0.6%
Onedrop Liquid
FDA Label NDC 57619-306
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratorios Sophia, S.a. De C.v. for the product Onedrop (NDC 57619-306). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Do Not Use
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
Otc - When Using
When using this product
- Make sure the tip of container does not touch any surface to avoid contamination.
- Replace cap after each use
Otc - Stop 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
Otc - Keep Out Of Reach Of Children
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.
Otc - Questions
Questions?
Call +1 (612) 584-9232
www.TearRestore.com
[email protected]
Other
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
Package Label.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
* Please review the disclaimer below.
