Lubricant Drops: Package Insert and Label Information

LUBRICANT DROPS- carboxymethylcellulose sodium solution/ drops
Cardinal Health, 110 dba LEADER

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.

Active ingredient

Carboxymethylcellulose sodium 0.5%

Purpose

Eye lubricant

Uses

• For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
• For use as a protectant against further irritation or to relieve dryness of the eye.

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 or irritation of the eye, or if 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.

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.
  
• Discard 90 days after opening
  
• Store at 59°-86°F (15°-30°C).
  
• RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; stabilized oxychloro complex; and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

PRINCIPAL DISPLAY PANEL

LUBRICANT DROPS carboxymethylcellulose sodium solution/ drops

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0090 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBOXYMETHYLCELLULOSE SODIUM (CARBOXYMETHYLCELLULOSE) CARBOXYMETHYLCELLULOSE SODIUM 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength BORIC ACID CALCIUM CHLORIDE MAGNESIUM CHLORIDE POTASSIUM CHLORIDE WATER SODIUM CHLORITE SODIUM CHLORIDE HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70000-0090-1 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER 1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (70000-0090-1) 2 NDC:70000-0090-2 2 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER 2 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (70000-0090-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 03/09/2021

Labeler — Cardinal Health, 110 dba LEADER (063997360)

Revised: 06/2021 Cardinal Health, 110 dba LEADER