MOISTURIZING LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution/ drops
Chain Drug Consortium

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

Carboxymethylcellulose Sodium 0.5%

Purpose

Lubricant

Uses

for the temporary relief of burning irritation and discomfort due to dryness of the eye or exposure to the wind and sun
may be used as a protectant against further irritation

Warnings

for external use only
to avoid contamination, do not touch tip of container to any surface. Replace cap after using
if solution changes color or becomes cloudy, do not use

Stop use and ask a doctor if

you feel eye pain
changes in vision
continued redness or irritation of the eye(s) gets worse, persists or lasts 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 in the affected eye(s) as needed

Other information

do not use if seal on bottle is missing or broken
use before expiration date marked on container
store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
RETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive ingredients

Purified Water, Boric Acid, Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride.

May also contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH;

Preservative: Chlorine Dioxide 2% solution.

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

68016-405-00

Premier

Value® Logo

Moisturizing

Lubricant

Eye Drops

MOISTURIZING DROPS

FOR DRY EYES

CMC 0.5% Lubricant Eye Drops

15 mL (0.5 FL OZ)

STERILE

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

68016-405-00

*COMPARE TO THE

ACTIVE INGREDIENT

IN REFRESH TEARS®

Premier

Value® Logo

Moisturizing

Lubricant

Eye Drops

MOISTURIZING DROPS

FOR DRY EYES

CMC 0.5% Lubricant

Eye Drops

15 mL (0.5 FL OZ)

STERILE PV Brand Logo

Principal Display Panel Text for Carton Label

MOISTURIZING LUBRICANT EYE DROPS
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-405
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Carboxymethylcellulose Sodium (UNII: K679OBS311) (Carboxymethylcellulose - UNII:05JZI7B19X)	Carboxymethylcellulose Sodium	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Boric Acid (UNII: R57ZHV85D4)
Sodium Chloride (UNII: 451W47IQ8X)
Potassium Chloride (UNII: 660YQ98I10)
Calcium Chloride (UNII: M4I0D6VV5M)
Magnesium Chloride (UNII: 02F3473H9O)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Chlorine Dioxide (UNII: 8061YMS4RM)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68016-405-00	1 in 1 CARTON	01/10/2014	01/31/2017
1		15 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	01/10/2014	01/31/2017

Labeler - Chain Drug Consortium (101668460)

Revised: 10/2020

Document Id: 891e70b3-5819-4bb9-bf21-1562376f3ec4

Set id: 1af7e6c4-b25f-4edc-a625-a3e2ee0c9f51

Version: 3

Effective Time: 20201021

Chain Drug Consortium