THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops 
MEDTECH PRODUCTS INC

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.

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TheraTears PF 58790-000

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.

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Drug Facts

Active ingredient (In each unit dose)

Sodium Carboxymethylcellulose 0.25%

Purpose

Eye lubricant

Uses

Warnings

For external use only

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

Other information

Inactive ingredients

Borate buffers, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium bicarbonate, sodium chloride and sodium phosphate

Questions and comments?

1-800-579-8327

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

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

THERATEARS LUBRICANT 
carboxymethylcellulose sodium solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58790-000
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
carboxymethylcellulose sodium, unspecified form (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium, unspecified form2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
boric acid (UNII: R57ZHV85D4)  
sodium borate (UNII: 91MBZ8H3QO)  
calcium chloride (UNII: M4I0D6VV5M)  
magnesium chloride (UNII: 02F3473H9O)  
potassium chloride (UNII: 660YQ98I10)  
water (UNII: 059QF0KO0R)  
sodium bicarbonate (UNII: 8MDF5V39QO)  
sodium chloride (UNII: 451W47IQ8X)  
sodium phosphate (UNII: SE337SVY37)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58790-000-328 in 1 CARTON01/01/1995
14 in 1 POUCH
119.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2NDC:58790-000-246 in 1 CARTON01/01/1995
24 in 1 POUCH
219.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3NDC:58790-000-205 in 1 CARTON01/01/1995
34 in 1 POUCH
319.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
4NDC:58790-000-306 in 1 CARTON12/07/2018
45 in 1 POUCH
40.6 mL in 1 VIAL; Type 0: Not a Combination Product
5NDC:58790-000-006 in 1 CARTON12/07/2018
55 in 1 POUCH
50.6 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/01/1995
Labeler - MEDTECH PRODUCTS INC (114707784)

Revised: 3/2022
Document Id: f988872b-5780-457e-ad90-2ba437581e36
Set id: 797b0394-2f0f-4733-8d20-ec5bdf3e085d
Version: 9
Effective Time: 20220322
 
MEDTECH PRODUCTS INC