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ARTIFICIAL TEARS by Aru Pharma Inc.

Dosage form: solution/ drops
Ingredients: CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 10mg in 1mL
Labeler: Aru Pharma Inc.
NDC Code: 70403-921

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.

QPACK 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 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.

Inactive Ingredients

Boric Acid, Potassium Chloride, Sodium Chloride, Calcium Chloride Dihydrate, Magnesium Chloride, Sodium Chlorite, Sodium Hydroxide and Water for Injection .

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

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

ARTIFICIAL TEARS 
carboxymethylcellulose sodium solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-921
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (CARBOXYMETHYLCELLULOSE) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BORIC ACID 
POTASSIUM CHLORIDE 
SODIUM CHLORIDE 
CALCIUM CHLORIDE 
MAGNESIUM CHLORIDE 
SODIUM CHLORITE 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:70403-921-151 BOTTLE, DROPPER in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/22/2018
Labeler - Aru Pharma Inc. (079736192)

Revised: 12/2017
 
Aru Pharma Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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