Theratears Pf 58790-000

Theratears Pf 58790-000
SPL v11
SPL
SPL Set ID 797b0394-2f0f-4733-8d20-ec5bdf3e085d
Route
OPHTHALMIC
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (2.5 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Magnesium Chloride Potassium Chloride Sodium Bicarbonate Sodium Chloride Sodium Borate Water Sodium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1995-01-01
Description

THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops  Medtech Products Inc., a Prestige Consumer Healthcare company Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Drug Facts

Purpose

Eye lubricant

Medication Information

Purpose

Eye lubricant

Description

THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops  Medtech Products Inc., a Prestige Consumer Healthcare company Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Drug Facts

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.
Section 42229-5

THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops 

Medtech Products Inc., a Prestige Consumer Healthcare company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

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.
Directions
  • To open, twist tab completely off.

  • Instill 1 or 2 drops in the affected eye(s) as needed.
Do Not Use
  • If solution changes color or becomes cloudy.
Other Information
  • Store between 15-25 C (59-77F)

  • 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

Principal Display Panel

PRESERVATIVE FREE

thera

tears®

THERAPY FOR YOUR EYES TM

dry eye therapy

LUBRICANT

EYE DROPS

IMMEDIATE

LONG LASTING

RELIEF

30  STERILE Single-Use Vials

0.60 FL OZ (18.0mL) TOTAL

Questions and Comments?

1-800-579-8327

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.

Active Ingredient (in Each Unit Dose)

Sodium Carboxymethylcellulose 0.25%

Structured Label Content

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.
Section 42229-5 (42229-5)

THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops 

Medtech Products Inc., a Prestige Consumer Healthcare company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Purpose

Eye lubricant

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.
Directions
  • To open, twist tab completely off.

  • Instill 1 or 2 drops in the affected eye(s) as needed.
Do Not Use (Do not use)
  • If solution changes color or becomes cloudy.
Other Information (Other information)
  • Store between 15-25 C (59-77F)

  • Do not touch unit-dose tip to eye.
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

PRESERVATIVE FREE

thera

tears®

THERAPY FOR YOUR EYES TM

dry eye therapy

LUBRICANT

EYE DROPS

IMMEDIATE

LONG LASTING

RELIEF

30  STERILE Single-Use Vials

0.60 FL OZ (18.0mL) TOTAL

Questions and Comments? (Questions and comments?)

1-800-579-8327

Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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

Active Ingredient (in Each Unit Dose) (Active ingredient (In each unit dose))

Sodium Carboxymethylcellulose 0.25%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:49.041760 · Updated: 2026-03-14T23:13:10.446567