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PEG-Phen Lubricant Eye Drops

Dosage form: solution/ drops
Ingredients: Polyethylene Glycol 400 4mg in 1mL, Propylene Glycol 3mg in 1mL
Labeler: Amerisource Bergen
NDC Code: 46122-199

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

Other Information

  • Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive Ingredients:

Purified Water, Boric Acid, Hypromellose, Sodium Chloride, Potassium Chloride, Zinc Chloride, Calcium Chloride Diydrate, Magnesium Chloride Hexahydrate. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH;

Preservative: Benzalkonium Chloride.

Questions or comments?

1-800-579-8327

Principal Display Panel Text for Container Label:

46122-199-05

Good Neighbor Pharmacy Logo ®

Lubricant

Eye Drops

PEG-Phen Lubricant Eye Drops

Long Lasting

Soothing comfort dry eye therapy

15 mL (0.5 fl oz)

Sterile

Principal Display Panel Text for Carton Label:

46122-199-05

Compare to Systane®

active ingredients*

Good Neighbor Pharmacy Logo ®

Lubricant

Eye Drops

PEG-Phen

Lubricant Eye Drops

Long Lasting

Soothing comfort

dry eye therapy

15 mL

(0.5 fl oz)

Sterile

PEG-PHEN LUBRICANT EYE DROPS 
polyethylene glycol 400 and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-199
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 4004 mg  in 1 mL
Propylene Glycol (Propylene Glycol) Propylene Glycol3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Boric Acid 
Hypromelloses 
Sodium Chloride 
Potassium Chloride 
Zinc Chloride 
Calcium Chloride 
Magnesium Chloride 
Hydrochloric Acid 
Sodium Hydroxide 
Benzalkonium Chloride 
Packaging
#Item CodePackage Description
1NDC:46122-199-051 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 finalpart34903/22/2013
Labeler - Amerisource Bergen (007914906)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(46122-199), ANALYSIS(46122-199), STERILIZE(46122-199), PACK(46122-199), LABEL(46122-199)

Revised: 04/2013
 
Amerisource Bergen

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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