MOISTURIZING LUBRICANT- carboxymethylcellulose sodium solution/ drops 
Kroger Company

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

Warnings

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

Other Information

  • 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 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 Text for Container Label

Principal Display Panel Text for Carton Label:

COMPARE TO the active Ingredients 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)

Principal Display Panel Text for Carton Label
MOISTURIZING LUBRICANT 
carboxymethylcellulose sodium solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-338
Route of Administration OPHTHALMIC DEA Schedule     
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
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 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)

Revised: 2/2013
Document Id: a8713f2a-87fb-420b-b73c-91362bbfebc6
Set id: e4541486-78fe-4de9-91cd-71b52b93638b
Version: 1
Effective Time: 20130221
 
Kroger Company