Ultra lubricant eye drops solution/ drops

Spl unclassified section

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 25C (68to77F) [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

Ingredients and appearance - Product information

Ultra lubricant eye drops solution/ drops- Polyethylene glycol 400 and propylene glycol

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 68016-402
Route of Administration Ophthalmic

Active Ingredient/Active Moiety

Ingredient Name Strength
Polyethylene glycol 400 ( UNII: B697894SGQ)( Polyethylene glycol 400 - UNII: B697894SGQ ) 4 mgin 1 mL
Propylene glycol ( UNII: 6DC9Q167V3)( Propylene glycol - UNII: 6DC9Q167V3 ) 3 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
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)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part349 USA

Labeler - Chain Drug Consortium( 101668460)

Establishment

Name ID/FEI Business Operations
Chain Drug Consortium 101668460 MANUFACTURE( 68016-402), ANALYSIS( 68016-402), STERILIZE( 68016-402), PACK( 68016-402), LABEL( 68016-402)

Package label.principal display panel

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

Package label.principal display panel

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