Search by Drug Name or NDC

NDC 58790-0003-30 TheraTears 10 mg/mL Details

TheraTears 10 mg/mL

TheraTears is a OPHTHALMIC GEL 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	58790-0003
Product ID	58790-003_7fa25608-0b89-4e34-a2d8-1e64b46db208
Associated GPIs	86200010104031 80509904220120
GCN Sequence Number	062795
GCN Sequence Number Description	carboxymethylcellulose sodium DROPER GEL 1 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	98569
HICL Sequence Number	003843
HICL Sequence Number Description	CARBOXYMETHYLCELLULOSE SODIUM
Brand/Generic	Generic
Proprietary Name	TheraTears
Proprietary Name Suffix	n/a
Non-Proprietary Name	carboxymethylcellulose sodium
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	OPHTHALMIC
Active Ingredient Strength	10
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 58790-0003-30 (58790000330)

Pricing Information	N/A
NDC Package Code	58790-003-30
Billing NDC	58790000330
Package	6 POUCH in 1 CARTON (58790-003-30) / 5 VIAL in 1 POUCH / .6 mL in 1 VIAL
Marketing Start Date	2018-12-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 17a01236-130f-495b-9f8d-92b6a23b2dc5 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (In each unit dose)

sodium carboxymethylcellulose 1%

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 potential 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 or comments? 1-800-579-8327

Principal Display Panel Text for Carton Label:

PRESERVATIVE

FREE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

Liquid Gel

nighttime

dry eye therapy

LUBRICANT EYE GEL

SOOTHING

OVERNIGHT

RELIEF

30 STERILE

Single-Use Vials* 0.60 FL OZ (18.0 mL) TOTAL

Principal Display Panel Text for Carton Label:

PRESERVATIVE

FREE

RECOMMENDED

DOCTOR

CREATED

thera

tears®

THERAPY FOR YOUR EYES®

Liquid Gel

nighttime

dry eye therapy

LUBRICANT EYE GEL

SOOTHING

OVERNIGHT

RELIEF

4 Single-Use Vials 0.08 FL OZ (2.4 mL) TOTAL

INGREDIENTS AND APPEARANCE

THERATEARS

carboxymethylcellulose sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58790-002
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	10 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:58790-002-28	7 in 1 CARTON	12/01/2002
1		0.6 mL in 1 POUCH; 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	12/01/2002

THERATEARS

carboxymethylcellulose sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58790-003
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	10 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:58790-003-30	6 in 1 CARTON	12/07/2018
1		5 in 1 POUCH
1		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	12/07/2018

Labeler - MEDTECH PRODUCTS INC (114707784)

Name	Address	ID/FEI	Business Operations
Establishment
Laboratoire Unither		574139809	label(58790-002, 58790-003) , manufacture(58790-002, 58790-003) , pack(58790-002, 58790-003)

Revised: 3/2022

Document Id: 7fa25608-0b89-4e34-a2d8-1e64b46db208

Set id: 17a01236-130f-495b-9f8d-92b6a23b2dc5

Version: 9

Effective Time: 20220322

Search by Drug Name or NDC

NDC 58790-0003-30 TheraTears 10 mg/mL Details

TheraTears 10 mg/mL

Product Information

Package

Package Images

NDC 58790-0003-30 (58790000330)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 17a01236-130f-495b-9f8d-92b6a23b2dc5 Details

SPL UNCLASSIFIED SECTION

Active ingredient (In each unit dose)

Purpose

Uses

Warnings

Do not use

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Principal Display Panel Text for Carton Label:

Principal Display Panel Text for Carton Label:

INGREDIENTS AND APPEARANCE

Is Lipitor Safe To Take With Nattokinase?

Can You Take A Z-Pak If You Have A Penicillin Allergy?