Theratears Gel
FDA Label NDC 58790-003

11 label sections · Submitted to the FDA by Medtech Products Inc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medtech Products Inc for the product Theratears (NDC 58790-003). 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 active ingredient (in each unit dose), purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient (in Each Unit Dose)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel Text For Carton Label:

Active Ingredient (In Each Unit Dose)

sodium carboxymethylcellulose 1%

Purpose

Eye lubricant

Uses

As a lubricant to relieve dryness of the eye.
As a protectant against further irritation of the eye.
For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

Warnings

For external use only

To avoid contamination do not touch tip of opened container to any surface. Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch.
This product contains no preservatives. Any solution not used immediately after opening should be discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on potential contamination during handling.

Do Not Use

If solution changes color or becomes cloudy.

Stop Use And Ask A Doctor If

You experience eye pain, changes in vision, continued redness or irritation.
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 immediately.

Directions

To open, twist tab completely off.
Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

Store between 15C-25C (59F-77F)
Do not touch unit-dose tip to eye.

Inactive Ingredients

boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate,sodium chloride, sodium phosphate ,water

Questions or comments? 1-800-579-8327

Principal Display Panel Text For Carton Label:

PRESERVATIVE

FREE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

Liquid Gel

nighttime

dry eye therapy

LUBRICANT EYE GEL

SOOTHING

OVERNIGHT

RELIEF

30 STERILE

Single-Use Vials* 0.60 FL OZ (18.0 mL) TOTAL

Principal Display Panel Text For Carton Label:preservativefreerecommendeddoctorcreatedtheratears®therapy For Your Eyes®liquid Gelnighttimedry Eye Therapylubricant Eye Gelsoothingoverni (Theratears Liquid Night Pf 58790 003 01)