CARBOXYMETHYLCELLULOSE SODIUM gel

carboxymethylcellulose sodium by

Drug Labeling and Warnings

carboxymethylcellulose sodium by is a Otc medication manufactured, distributed, or labeled by AvPAK. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Carboxymethylcellulose sodium 1%

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.
• May be used as a protectant against further irritation.

Warnings

• For use in the eyes 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 this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

Shake well before use.

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

Other information

• Do Not Use if imprinted seal on cap is torn, broken or missing.
• Discard 90 days after opening.
• Store at room temperature 15°-30°C (59°-86°F).
• Retain outer carton for full product drug information.

Inactive ingredients

Boric acid, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride. Stabilized Oxychloro Complex 2.5%. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

1-855-361-3993

Distributed by:
AvKARE

Pulaski, TN 38478

Rev. 09/2020 AV 09/2020

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CARBOXYMETHYLCELLULOSE SODIUM 
carboxymethylcellulose sodium gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50268-066
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X)	CARBOXYMETHYLCELLULOSE SODIUM	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50268-066-15	1 in 1 CARTON	11/18/2020
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 Drug	M018	11/18/2020

Labeler - AvPAK (832926666)