CMC LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution/ drops

CMC Lubricant Eye Drops by

Drug Labeling and Warnings

CMC Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, 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 experience eye pain
• changes in vision
• continued redness
• irritation of the eye
• the 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 in the affected eye(s) as needed.

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Other information

• Do not use if seal on bottle is missing or broken.
• Use before expiration date marked on container.
• 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

Questions or comments?

1-800-579-8327

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

46122-200-05

Good Neighbor Pharmacy Logo ®

Lubricant

Eye Drops

CMC 0.5% Lubricant Eye Drops

15 mL (0.5 fl oz)

Sterile

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

46122-200-05

Compare to

Refresh Tears®

active ingredients*

Good Neighbor Pharmacy Logo ®

Lubricant

Eye Drops

CMC 0.5%

Lubricant Eye Drops

Moisturizing Drops

for Dry Eyes

15 mL

(0.5 fl oz)

Sterile

INGREDIENTS AND APPEARANCE

CMC LUBRICANT EYE DROPS 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-200
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: 46122-200-05	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/22/2013

Labeler - Amerisource Bergen (007914906)

Registrant - Akorn, Inc. (063434679)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(46122-200) , ANALYSIS(46122-200) , STERILIZE(46122-200) , PACK(46122-200) , LABEL(46122-200)