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NDC 58790-0007-16 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 FORM.

Product Information

NDC	58790-0007
Product ID	58790-007_bdf0c6be-3cf1-43ba-a7ac-c3e8aa02024e
Associated GPIs
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 Extra
Proprietary Name Suffix	n/a
Non-Proprietary Name	Carboxymethylcellulose Sodium, Unspecified Form
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 58790-0007-16 (58790000716)

Pricing Information	N/A
NDC Package Code	58790-007-16
Billing NDC	58790000716
Package	2 BOTTLE, DROPPER in 1 CARTON (58790-007-16) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 77f504c1-b8e0-4371-ac3e-9d453d84714b 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 risk of contamination do not touch tip of opened container to any surface. Replace cap tightly after each use.

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

Instill 1 or 2 drops of TheraTears® Extra® 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

Boric acid, calcium chloride, Dequest®, 2060S phosphonate, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium perborate, sodium phosphate, trehalose, and water for injection.

Questions or comments?

1-800-579-8327

Principal Display Panel Text for Container Label:

thera

tears®

THERAPY FOR YOUR EYES®

EXTRA®

dry eye therapy

LUBRICANT

EYE DROPS

EXTRA MOISTURIZING

√ Rehydrates

√ Protects

√ Supports pH Level

STERILE

Multi-Use

Bottle TWO 0.5 FL OZ (15 mL) BOTTLES

Principal Display Panel Text for Carton Label:

RECOMMENDED

DOCTOR

CREATED