MOISTURIZING LUBRICANT- carboxymethylcellulose sodium solution/ drops

moisturizing lubricant by

Drug Labeling and Warnings

moisturizing lubricant by is a Otc medication manufactured, distributed, or labeled by Kroger Company, 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 occur.
• 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 (1 -800-222-1222).

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

• Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
• Use before expiration date marked on container.

• Storage: 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?

1-800-632-6900

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

30142-338-04

Kroger Logo®

STERILE

eye drops

moisturizing

lubricant

CMC 0.5% Lubricant Eyedrops

0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

COMPARE TO the active Ingredient of

REFRESH TEARS®*See side panel

30142-338-04

Kroger Logo®

FROM OUR FAMILY

TO YOURS

STERILE

eye drops

moisturizing

lubricant

CMC 0.5% Lubricant Eyedrops

Lubricant eye drops

Moisturizing Drops

for Dry Eyes

0.5 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

MOISTURIZING LUBRICANT 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-338
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: 30142-338-04	1 in 1 CARTON	02/22/2013
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	02/22/2013

Labeler - Kroger Company (006999528)

Registrant - Akorn, Inc. (063434679)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE(30142-338) , ANALYSIS(30142-338) , STERILIZE(30142-338) , PACK(30142-338) , LABEL(30142-338)