ARTIFICIAL TEARS- carboxymethylcellulose sodium liquid
Delsam Pharma Llc

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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Delsam Pharma's ARTIFICIAL TEARS

Drug Facts

Active Ingredient

Carboxymethylcellulose Sodium 10 MG in 1 ml.

Purpose

Eye Lubricant

Uses

for use as a protectant against further irritation or to relieve dryness of the eye
for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

For external use only

• Do not use this product if solution changes color or becomes cloudy

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

When using this product

• to avoid contamination. do not touch tip of container to any surface • replace cap after using. Keep container tightly closed.

• remove contact lens before using

Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Directions

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

Other information

Tamper Evident. Do not use this product if neckband is missing or broken.
RETAIN THIS CARTON FOR FUTURE REFERENCE
Store at 15°-30°C (59°-86°F)

Inactive Ingredients

Boric Acid

Potassium Chloride

Sodium Chloride

Calcium Chloride Dihydrate.

Magnesium Chloride

Sodium Chlorite

Sodium Hydroxide and Water for Injection

Questions or comments?

1-866-826-1306

between 9 am and 4 pm EST, Monday-Friday.

Compare to the active Ingredient in Refresh Plus Eye Drops

Carboxymethylcellulose Sodium 1%

Lubricant Eye Drops

Refresh, Lubricate and Moisturizes

Distributed by:

Delsam Pharma Llc

Bronx, Newyork 10467.

Packaging

untitled

ARTIFICIAL TEARS
carboxymethylcellulose sodium liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72570-121
Route of Administration	OPHTHALMIC

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

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
SODIUM CHLORITE (UNII: G538EBV4VF)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72570-121-15	1 in 1 CARTON	07/23/2020	01/30/2023
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	07/23/2020	01/30/2023

Labeler - Delsam Pharma Llc (081369679)

Revised: 3/2023

Document Id: e7c36253-3970-4ed6-bdc3-cc4439be2f02

Set id: fbbfda9c-588b-4e82-b66c-83cea663b967

Version: 3

Effective Time: 20230315

Delsam Pharma Llc