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Artificial Tears by MWI

Medically reviewed on March 23, 2018

Dosage form: solution/ drops
Ingredients: Polyvinyl Alcohol 14mg in 1mL
Labeler: MWI
NDC Code: 13985-601

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 ingredient

Polyvinyl Alcohol 1.4%

Purpose

Eye lubricant

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Warnings
  • Do not use if imprinted seal on the bottle neck is broken or missing.
  • Do not use if solution changes color or becomes cloudy.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

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.

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

Directions

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

Other information
  • Store at 20° to 25°C (68° to 77°F)
    [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Purified Water USP, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Questions?

call toll-free 1-800-932-5676.

Principal Display Panel Text for Container Label:

NDC 13985-601-15

Artificial Tears

Solution

Polyvinyl Alcohol 1.4%

STERILE

Lubricant Eye Drops

Apexa logo

AP 704002 15 mL

Principal Display Panel Text for Carton Label:

NDC 13985-601-15

Artificial Tears

Solution

Polyvinyl Alcohol 1.4%

STERILE

Lubricant Eye Drops

Prevents Irritation

and Relieves

Dryness of the eye

Apexa logo

AP 704002 15 mL

ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13985-601
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyvinyl Alcohol (Polyvinyl Alcohol) Polyvinyl Alcohol14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride 
Edetate Disodium 
Sodium Chloride 
Sodium Phosphate, Dibasic, Anhydrous 
Sodium Phosphate, Monobasic, Anhydrous 
Water 
Sodium Hydroxide 
Hydrochloric Acid 
Packaging
#Item CodePackage Description
1NDC:13985-601-151 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 finalpart34903/23/2015
Labeler - MWI (019926120)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(13985-601), ANALYSIS(13985-601), STERILIZE(13985-601), PACK(13985-601), LABEL(13985-601)

 
MWI

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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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