theratears dry and tired dry eye therapy pf - 58790-013

theratears dry and tired dry eye therapy pf - 58790-013
SPL v2
SPL
SPL Set ID 02b70e2d-8159-4637-a282-9eac1468e786
Route
ophthalmic
Published
Effective Date 2026-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
carboxymethylcellulose (5 mg)
Inactive Ingredients
calcium chloride magnesium chloride potassium chloride water sodium chloride sodium lactate hydrochloric acid sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-30

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


Medication Information

Warnings

For use in the eyes only.

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

  • For the temporary relief of discomfort due to minor irritations of the eye or from exposure to wind and sun.

  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Purpose

Eye lubricant

Directions
  • To open, twist tab completely off.

  • Instill 1 or 2 drops into affected eye(s) as needed and discard container.
Other Information
  • Store between 15º-30ºC (59º-86ºF).
Inactive Ingredients

Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

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

Principal Display Panel

Carboxymethylcellulose sodium 0.5%

LUBRICANT EYE DROPS

DRY & TIRED

dry eye therapy

PRESERVATIVE FREE

30 STERILE

Single-Use Vials

0.4 FL OZ (12 mL) TOTAL

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

Do Not Use

if solution changes color or becomes cloudy.

Questions and Comments?

1-800-579-8327

When Using This Product

■ do not touch tip of container to any surface to avoid contamination.

■ do not reuse; once opened discard.

Stop Use and Ask A Doctor If

■ you experience eye pain, changes in vision, continued redness or irritation of the eye.

■ the 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.

Active Ingredient (in Each Unit Dose)

Sodium Carboxymethylcellulose 0.5%


Structured Label Content

Warnings

For use in the eyes only.

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

  • For the temporary relief of discomfort due to minor irritations of the eye or from exposure to wind and sun.

  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
Purpose

Eye lubricant

Directions
  • To open, twist tab completely off.

  • Instill 1 or 2 drops into affected eye(s) as needed and discard container.
Other Information (Other information)
  • Store between 15º-30ºC (59º-86ºF).
Inactive Ingredients (Inactive ingredients)

Calcium chloride, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

Carboxymethylcellulose sodium 0.5%

LUBRICANT EYE DROPS

DRY & TIRED

dry eye therapy

PRESERVATIVE FREE

30 STERILE

Single-Use Vials

0.4 FL OZ (12 mL) TOTAL

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

Do Not Use (Do not use)

if solution changes color or becomes cloudy.

Questions and Comments? (Questions and comments?)

1-800-579-8327

When Using This Product (When using this product)

■ do not touch tip of container to any surface to avoid contamination.

■ do not reuse; once opened discard.

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 of the eye.

■ the 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 right away.

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

Sodium Carboxymethylcellulose 0.5%


Advanced Ingredient Data


Raw Label Data

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