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NDC 58790-0001-31 TheraTears Lubricant 2.5 mg/mL Details

TheraTears Lubricant 2.5 mg/mL

TheraTears Lubricant is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by MEDTECH PRODUCTS INC. The primary component is CARBOXYMETHYLCELLULOSE SODIUM.

Product Information

NDC	58790-0001
Product ID	58790-001_a536ead7-0286-4223-873b-4129c70a2175
Associated GPIs	86200010102010
GCN Sequence Number	024192
GCN Sequence Number Description	carboxymethylcellulose sodium DROPS 0.25 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	37382
HICL Sequence Number	003843
HICL Sequence Number Description	CARBOXYMETHYLCELLULOSE SODIUM
Brand/Generic	Brand
Proprietary Name	TheraTears Lubricant
Proprietary Name Suffix	n/a
Non-Proprietary Name	carboxymethylcellulose sodium
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	2.5
Active Ingredient Units	mg/mL
Substance Name	CARBOXYMETHYLCELLULOSE SODIUM
Labeler Name	MEDTECH PRODUCTS INC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58790-0001-31 (58790000131)

Pricing Information	N/A
NDC Package Code	58790-001-31
Billing NDC	58790000131
Package	2 BOTTLE, DROPPER in 1 CARTON (58790-001-31) / 30 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 661d8764-8ae6-4229-9485-867553ee8e16 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium carboxy-

methylcellulose 0.25%

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. Replace cap after using.

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

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

Other information

Do not use if neck ring is broken or missing.
Discard 45 days after opening.

Inactive ingredients

Borate buffers, calcium chloride, Dequest®, magnesium chloride, potassium chloride, sodium bicarbonate, sodium chloride, sodium perborate, sodium phosphate, and water for injection.

Questions or comments?

1-800-579-8327

Principal Display Panel Text for Carton Label:

VALUE SIZE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

dry eye therapy

LUBRICANT

EYE DROPS

IMMEDIATE

LONG LASTING

RELIEF

STERILE

Multi-Use Bottle*

1 FL OZ (30 mL)

INGREDIENTS AND APPEARANCE

THERATEARS LUBRICANT

carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58790-001
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X)	carboxymethylcellulose sodium	2.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
boric acid (UNII: R57ZHV85D4)
sodium perborate (UNII: Y52BK1W96C)
calcium chloride (UNII: M4I0D6VV5M)
diethylenetriamine pentamethylene phosphonic acid (UNII: 0Q75589TM3)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
water (UNII: 059QF0KO0R)
sodium bicarbonate (UNII: 8MDF5V39QO)
sodium chloride (UNII: 451W47IQ8X)
sodium phosphate (UNII: SE337SVY37)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58790-001-30	1 in 1 CARTON	07/01/1999
1		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:58790-001-15	1 in 1 CARTON	07/01/1999
2		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC:58790-001-31	2 in 1 CARTON	12/01/2020
3		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	07/01/1999

Labeler - MEDTECH PRODUCTS INC (114707784)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn AG		482198285	analysis(58790-001) , label(58790-001) , manufacture(58790-001) , pack(58790-001)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn Operating Company LLC (dba Akorn)		117696790	label(58790-001) , pack(58790-001)

Name	Address	ID/FEI	Business Operations
Establishment
Akorn Operating Company LLC (dba Akorn)		117696832	analysis(58790-001) , manufacture(58790-001) , sterilize(58790-001)

Revised: 3/2022

Document Id: a536ead7-0286-4223-873b-4129c70a2175

Set id: 661d8764-8ae6-4229-9485-867553ee8e16

Version: 8

Effective Time: 20220308