Your browser does not support JavaScript! MOISTURIZING LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [KROGER COMPANY]
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MOISTURIZING LUBRICANT (carboxymethylcellulose sodium) solution/ drops
[Kroger Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-338
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carboxymethylcellulose Sodium (Carboxymethylcellulose) Carboxymethylcellulose Sodium5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Boric Acid 
Sodium Chloride 
Potassium Chloride 
Calcium Chloride 
Magnesium Chloride 
Hydrochloric Acid 
Sodium Hydroxide 
Chlorine Dioxide 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-338-041 in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/22/2013
Labeler - Kroger Company (006999528)
Registrant - Akorn, Inc. (063434679)
Establishment
NameAddressID/FEIBusiness Operations
Akorn, Inc603980319MANUFACTURE(30142-338), ANALYSIS(30142-338), STERILIZE(30142-338), PACK(30142-338), LABEL(30142-338)

Revised: 2/2013
 
Kroger Company

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