ARTIFICIAL TEARS- carboxymethylcellulose sodium solution/ drops

ARTIFICIAL TEARS by

Drug Labeling and Warnings

ARTIFICIAL TEARS by is a Otc medication manufactured, distributed, or labeled by Aru Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 the 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

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Refresh Plus Eye drops

Lubricant Eye Drops

Refresh, Lubricate and Moisturizes

Distributed by.

ARU PHARMA INC.

MOUNT VERNON, NY 10552

www.qpackrx.com

Packaging

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS 
carboxymethylcellulose sodium solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70403-921
Route of Administration	OPHTHALMIC

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70403-921-15	1 in 1 CARTON	01/22/2018
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 final	part349	01/22/2018

Labeler - Aru Pharma Inc. (079736192)