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NDC 58790-0000-24 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, UNSPECIFIED FORM.

Product Information

NDC	58790-0000
Product ID	58790-000_f988872b-5780-457e-ad90-2ba437581e36
Associated GPIs	86200010102011
GCN Sequence Number	030012
GCN Sequence Number Description	carboxymethylcellulose sodium DROPERETTE 0.25 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	37385
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, UNSPECIFIED FORM
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 58790-0000-24 (58790000024)

Pricing Information	N/A
NDC Package Code	58790-000-24
Billing NDC	58790000024
Package	6 POUCH in 1 CARTON (58790-000-24) / 4 APPLICATOR in 1 POUCH / 19.2 mL in 1 APPLICATOR
Marketing Start Date	1995-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 797b0394-2f0f-4733-8d20-ec5bdf3e085d Details

SPL UNCLASSIFIED SECTION

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

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. 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 ptential contamination during handling.

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

To open, twist tab completely off.
Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

Use only if foil pouch is sealed and single-use container is intact.
Do not touch unit-dose tip to eye.

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

INGREDIENTS AND APPEARANCE

THERATEARS LUBRICANT

carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58790-000
Route of Administration	OPHTHALMIC

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58790-000-32	8 in 1 CARTON	01/01/1995
1		4 in 1 POUCH
1		19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC:58790-000-24	6 in 1 CARTON	01/01/1995
2		4 in 1 POUCH
2		19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
3	NDC:58790-000-20	5 in 1 CARTON	01/01/1995
3		4 in 1 POUCH
3		19.2 mL in 1 APPLICATOR; Type 0: Not a Combination Product
4	NDC:58790-000-30	6 in 1 CARTON	12/07/2018
4		5 in 1 POUCH
4		0.6 mL in 1 VIAL; Type 0: Not a Combination Product
5	NDC:58790-000-00	6 in 1 CARTON	12/07/2018
5		5 in 1 POUCH
5		0.6 mL in 1 VIAL; 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	01/01/1995

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