MOISTURIZING LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution/ drops

Moisturizing Lubricant Eye Drops by

Drug Labeling and Warnings

Moisturizing Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, Akorn, Inc., Akorn, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

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

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

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-405-00	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	01/10/2014

Labeler - Chain Drug Consortium (101668460)

Registrant - Akorn, Inc. (063434679)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(68016-405) , ANALYSIS(68016-405) , STERILIZE(68016-405) , PACK(68016-405) , LABEL(68016-405)