Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% by

Drug Labeling and Warnings

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% by is a Otc medication manufactured, distributed, or labeled by EMC Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CARBOXYMETHYLCELLULOSE SODIUM OPHTHALMIC SOLUTION 0.5%- carboxymethylcellulose sodium solution/ drops 
EMC Pharma, LLC

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Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%

Active ingredient

Carboxymethylcellulose sodium 0.5%

Purpose

Eye Lubricant

Use

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 protectant against further irritation.

Warnings

For use in the eyes only

Do not use

If solution changes color or becomes cloudy.

When using this product

Avoid contamination, do not touch tip of container to any surface.
Replace cap after use.

Stop use and ask a doctor if

You experience eye pain, changes in vision, continued redness or irritation of the eye.
The condition worsens or persists for more than 72 hours

Keep this and all drugs out of the reach of the 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

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

Inactive Ingredient

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?

1-855-317-1107

Distributed By:
EMC Pharma, LLC
11551 Adie Rd, Maryland Heights, MO 63043

Rev. 10/2021

Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% (NDC 81288-798-15)

CARBOXYMETHYLCELLULOSE SODIUM OPHTHALMIC SOLUTION 0.5% 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81288-798
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
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)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81288-798-15	1 in 1 CARTON	01/01/2022	03/05/2024
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	01/01/2022	03/05/2024

Labeler - EMC Pharma, LLC (117754047)

Registrant - EMC Pharma, LLC (117754047)

Revised: 3/2024

Document Id: 2900f493-1948-4a6a-a7d0-59b5562a5e0f

34390-5

Set id: 0c911be8-265b-45e2-af4b-de8c12782c4b

Version: 2

Effective Time: 20240306