ARTIFICIAL TEARS- polyvinyl alcohol, unspecified solution/ drops 
Akorn

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.

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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

Inactive ingredients

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

Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

Principal Display Panel Text for Container Label:

NDC 17478-060-12

Artificial

Tears

Solution

Polyvinyl

Alcohol 1.4%

Lubricant

Eye Drops

Sterile

15 mL (0.5 fl. oz.)

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 17478-060-12

15 mL

Artificial

Tears

Solution

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

Prevents Irritation and Relieves

Dryness of the Eye

Sterile

15 mL (0.5 fl. oz.)

Principal Display Panel Text for Carton Label
ARTIFICIAL TEARS 
polyvinyl alcohol, unspecified solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17478-060
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) (Polyvinyl Alcohol, Unspecified - UNII:532B59J990) Polyvinyl Alcohol, Unspecified14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Edetate Disodium (UNII: 7FLD91C86K)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
Sodium Phosphate, Monobasic, Anhydrous (UNII: KH7I04HPUU)  
Water (UNII: 059QF0KO0R)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Hydrochloric Acid (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:17478-060-121 in 1 CARTON03/01/1998
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/01/1998
Labeler - Akorn (117696770)
Registrant - Akorn Operating Company LLC (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE(17478-060) , ANALYSIS(17478-060) , STERILIZE(17478-060) , PACK(17478-060) , LABEL(17478-060)

Revised: 1/2022
Document Id: 05d14c58-ab14-4ccf-bad4-97b916ed55f3
Set id: 736f9577-d8ff-45c7-8205-dfdb7193492f
Version: 5
Effective Time: 20220121
 
Akorn