theratears md 58790-001

theratears md 58790-001
SPL v10
SPL
SPL Set ID 661d8764-8ae6-4229-9485-867553ee8e16
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 sodium perborate calcium chloride diethylenetriamine pentamethylene phosphonic acid magnesium chloride potassium chloride water sodium bicarbonate sodium chloride sodium phosphate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 1999-07-01

Purpose

Eye lubricant

Description

Drug Facts


Medication Information

Warnings

For external use only

  • To avoid contamination do not touch tip of opened container to any surface. Replace cap after using.
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.
Purpose

Eye lubricant

Directions
  • Instill 1 or 2 drops in the affected eye(s) as needed.

  • After use and prior to re-capping, shake any residual product from the dropper tip.
Other Information
  • Store between 15-25C (59-77F)

  • Discard 45 days after opening.
Inactive Ingredients

boric acid, calcium chloride, diethylenetriamine pentamethylene phosphonic acid, hydrochloric acid, magnesium chloride, phosphonic acid, potassium chloride, sodium bicarbonate, sodium chloride, sodium perborate, sodium phosphate, water

Description

Drug Facts

Section 42229-5

Drug Facts

Do Not Use
  • If solution changes color or becomes cloudy.
Active Ingredient

Sodium carboxy-

methylcellulose 0.25%

Questions Or 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.

Principal Display Panel Text for Carton Label:

thera

tears®

LUBRICANT

EYE DROPS

1 FL OZ (30 mL)


Structured Label Content

Warnings

For external use only

  • To avoid contamination do not touch tip of opened container to any surface. Replace cap after using.
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.
Purpose

Eye lubricant

Directions
  • Instill 1 or 2 drops in the affected eye(s) as needed.

  • After use and prior to re-capping, shake any residual product from the dropper tip.
Other Information (Other information)
  • Store between 15-25C (59-77F)

  • Discard 45 days after opening.
Inactive Ingredients (Inactive ingredients)

boric acid, calcium chloride, diethylenetriamine pentamethylene phosphonic acid, hydrochloric acid, magnesium chloride, phosphonic acid, potassium chloride, sodium bicarbonate, sodium chloride, sodium perborate, sodium phosphate, water

Section 42229-5 (42229-5)

Drug Facts

Do Not Use (Do not use)
  • If solution changes color or becomes cloudy.
Active Ingredient (Active ingredient)

Sodium carboxy-

methylcellulose 0.25%

Questions Or Comments? (Questions or 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.

Principal Display Panel Text for Carton Label:

thera

tears®

LUBRICANT

EYE DROPS

1 FL OZ (30 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)