FDA Label for Onedrop

View Indications, Usage & Precautions

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
DOSAGE & ADMINISTRATION
OTHER INFORMATION
INACTIVE INGREDIENT
OTC - QUESTIONS
OTHER
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
SAMPLE BOX LABEL

Onedrop Product Label

The following document was submitted to the FDA by the labeler of this product Laboratorios Sophia, S.a. De C.v.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient

Active ingredient

Propylene Glycol 0.6%

Otc - Purpose

Purpose

Lubricant eye drops

Indications & Usage

Uses

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

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