ULTRA LUBRICANT EYE DROPS- polyethylene glycol 400 and propylene glycol solution/ drops 
Chain Drug Consortium

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 ingredients

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

Purpose

Lubricant

Lubricant

Uses

For the temporary relief of burning and irritation due to dryness of the eye.

Warnings

For external use only.

Do not use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before using
  • instill 1 or 2 drops in the affected eye(s) as needed.

Other information

  • store at 20° to 25°C (68°to77°F) [see USP Controlled Room Temperature].

Inactive ingredients

Purified Water, Sorbitol solution, Boric Acid, 2-amino-2-methyl-1-propanol, Hypromellose USP, Sodium Chloride, Potassium Chloride. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH;

Preservative

Benzalkonium Chloride.

Questions or comments?

1-800-932-5676

Principal Display Panel Text for Container Label:

NDC 68016-402-00

Premier

Value® Logo

Ultra Lubricant

Eye Drops

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

10 mL (0.34 FL OZ) STERILE

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 68016-402-00

*COMPARE TO THE

ACTIVE INGREDIENT

IN SYSTANE® ULTRA

Premier

Value® Logo

Ultra

Lubricant

Eye Drops

Polyethylene Glycol 400 0.4%

Propylene Glycol 0.3%

  • Lubricant eye drops for irritated eyes
  • Long lasting protection
  • Fast relief

10 mL (0.34 FL OZ)

STERILE PV Brand Logo

Principal Display Panel Text for Carton Label
ULTRA LUBRICANT EYE DROPS 
polyethylene glycol 400 and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-402
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 4004 mg  in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Boric Acid (UNII: R57ZHV85D4)  
Aminomethylpropanol (UNII: LU49E6626Q)  
Hypromelloses (UNII: 3NXW29V3WO)  
Sodium Chloride (UNII: 451W47IQ8X)  
Potassium Chloride (UNII: 660YQ98I10)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-402-001 in 1 CARTON01/10/201401/31/2017
110 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 finalpart34901/10/201401/31/2017
Labeler - Chain Drug Consortium (101668460)

Revised: 10/2020
Document Id: 13c363f7-1600-4772-9a08-0e7a39aa332d
Set id: 9ca6cfb5-e942-4907-be8e-a24e8895d6cf
Version: 3
Effective Time: 20201021
 
Chain Drug Consortium