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NDC 58790-0010-30 TheraTears Extra 2.5 mg/mL Details

TheraTears Extra 2.5 mg/mL

TheraTears Extra 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.

Product Information

NDC	58790-0010
Product ID	58790-010_735d60b9-9999-4e46-827c-abf2a2b70401
Associated GPIs
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 Extra
Proprietary Name Suffix	n/a
Non-Proprietary Name	Carboxymethylcellulose Sodium, Unspecified
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
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 58790-0010-30 (58790001030)

Pricing Information	N/A
NDC Package Code	58790-010-30
Billing NDC	58790001030
Package	6 POUCH in 1 CARTON (58790-010-30) / 5 VIAL, SINGLE-USE in 1 POUCH / .6 mL in 1 VIAL, SINGLE-USE
Marketing Start Date	2021-01-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f1845041-9d8d-42a0-a2cb-68def7a5aac7 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium carboxymethylcellulose 0.25%

Purpose

Eye lubricant

Uses

For use as a protectant against further irritation or to relieve dryness of the eye.
For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

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 he 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 right away.

Directions

To open, twist tab completely off.
Instill 1 or 2 drops of TheraTears® EXTRA® 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

Boric acid, calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium hydroxide*, sodium phosphate, trehalose, and water for injection. *May contain these ingredients to adjust pH.

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®

EXTRA®

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

√ Rehydrates

√ Protects

√ Supports pH Level

30 STERILE

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

INGREDIENTS AND APPEARANCE

THERATEARS EXTRA

carboxymethylcellulose sodium, unspecified solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58790-010
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X)	Carboxymethylcellulose Sodium, Unspecified	2.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Boric Acid (UNII: R57ZHV85D4)
calcium chloride (UNII: M4I0D6VV5M)
hydrochloric acid (UNII: QTT17582CB)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
sodium bicarbonate (UNII: 8MDF5V39QO)
sodium borate (UNII: 91MBZ8H3QO)
sodium chloride (UNII: 451W47IQ8X)
sodium hydroxide (UNII: 55X04QC32I)
sodium phosphate (UNII: SE337SVY37)
trehalose (UNII: B8WCK70T7I)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58790-010-30	6 in 1 CARTON	01/21/2021
1		5 in 1 POUCH
1		0.6 mL in 1 VIAL, SINGLE-USE; 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	01/21/2021

Labeler - MEDTECH PRODUCTS INC (114707784)

Revised: 3/2022

Document Id: 735d60b9-9999-4e46-827c-abf2a2b70401

Set id: f1845041-9d8d-42a0-a2cb-68def7a5aac7

Version: 3

Effective Time: 20220322