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Artificial Tears Lubricant Eye

Medically reviewed on Feb 9, 2018

Dosage form: solution/ drops
Ingredients: POLYVINYL ALCOHOL 500mg in 100mL, POVIDONE 600mg in 100mL
Labeler: WinCo Foods, LLC
NDC Code: 67091-284

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.

​Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

​Purpose

Polyvinyl alcohol: Eye Lubricant

Povidone: 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 imprinted neckband is missing or broken.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at 15°-30°C (59°-86°F)

Inactive ingredients

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

ARTIFICIAL TEARS LUBRICANT EYE 
polyvinyl alcohol, povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-284
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL500 mg  in 100 mL
POVIDONE (POVIDONE) POVIDONE600 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
DEXTROSE 
edetate disodium 
POTASSIUM CHLORIDE 
WATER 
SODIUM BICARBONATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC 
Packaging
#Item CodePackage Description
1NDC:67091-284-151 BOTTLE, DROPPER in 1 BOX
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/09/2015
Labeler - WinCo Foods, LLC (056098817)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIOperations
KC Pharmaceuticals, Inc.174450460manufacture(67091-284), label(67091-284), pack(67091-284)

 
WinCo Foods, LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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