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Artificial Tears by KC Pharmaceuticals, Inc.

Medically reviewed on May 14, 2018

Dosage form: solution/ drops
Ingredients: POLYVINYL ALCOHOL 5mg in 1mL, POVIDONE 6mg in 1mL
Labeler: KC Pharmaceuticals, Inc.
NDC Code: 55651-008

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.

Drug Facts

Active Ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purpose

Polyvinyl alcohol - Eye lubricant

Povidone - Eye lubricant

Keep out of reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

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

Directions

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

Inactive Ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic

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

Principal Display Panel

ARTE

ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-008
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL5 mg  in 1 mL
POVIDONE (POVIDONE) POVIDONE6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE0.1 mg  in 1 mL
DEXTROSE 
EDETATE DISODIUM 
POTASSIUM CHLORIDE 
WATER 
SODIUM BICARBONATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SODIUM PHOSPHATE, DIBASIC ANHYDROUS 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:55651-008-011 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/25/2003
Labeler - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIOperations
KC Pharmaceuticals, Inc.174450460manufacture

 
KC Pharmaceuticals, 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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