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Eye Drops SY

Dosage form: solution/ drops
Ingredients: POLYETHYLENE GLYCOL 400 4mg in 1mL, PROPYLENE GLYCOL 3mg in 1mL
Labeler: KC Pharmaceuticals, Inc.
NDC Code: 55651-028

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

Polyethylene glycol 400 - Lubricant

Propylene glycol - Lubricant

Keep out of reach of children.

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

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 the 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 or lasts more than 72 hours

Directions
  • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Children under 6 years of age: ask a doctor

Inactive Ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride

Other information
  • Tamper Evident.  Do not use this product if imprinted neckband on bottle is broken or missing.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at room temperature

Principal Display Panel

EDSY

EYE DROPS SY 
polyethylene glycol 400, propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-028
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
BENZALKONIUM CHLORIDE0.1 mg  in 1 mL
BORIC ACID 
CALCIUM CHLORIDE 
HYPROMELLOSES 
MAGNESIUM CHLORIDE 
POTASSIUM CHLORIDE 
WATER 
SODIUM BORATE 
SODIUM CHLORIDE 
ZINC CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:55651-028-011 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/17/2010
Labeler - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIOperations
KC Pharmaceuticals, inc.174450460manufacture

Revised: 05/2011
 
KC Pharmaceuticals, Inc.

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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