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Eye Drops Lubricating Tears

Dosage form: solution/ drops
Ingredients: HYPROMELLOSES 2mg in 1mL, GLYCERIN 2mg in 1mL, POLYETHYLENE GLYCOL 400 10mg in 1mL
Labeler: KC Pharmaceuticals, Inc.
NDC Code: 55651-026

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

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Purpose

Glycerin - Lubricant

Hypromellose - Lubricant

Polyethylene glycol 400 - Lubricant

Keep out of reach of children.

If accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Uses
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for protection against further irritation

Warnings

For external use only

  • Do not use this product if solution changes color or becomes cloudy

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

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using.  Keep container tightly closed.
  • remove contact lens before using

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

Inactive Ingredients

dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water

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 15o - 30oC (59o - 86oF)

If pregnant or breast feeding,

ask a health professional before use

Principal Display Panel

EDLT

EYE DROPS LUBRICATING TEARS 
hypromellose, glycerin, polyethylene glycol 400 solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-026
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSES (HYPROMELLOSES) HYPROMELLOSES2 mg  in 1 mL
GLYCERIN (GLYCERIN) GLYCERIN2 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
DEXTROSE 
EDETATE DISODIUM 
POTASSIUM CHLORIDE 
WATER 
SODIUM BICARBONATE 
SODIUM CHLORIDE 
SODIUM CITRATE 
SODIUM PHOSPHATE, DIBASIC ANHYDROUS 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:55651-026-011 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 finalpart34905/12/2008
Labeler - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIOperations
KC Pharmaceuticals, Inc.174450460manufacture

Revised: 05/2011
Document Id: 584b030c-552a-499d-95b1-9ff4c07fe0d1
Set id: 5ac223b9-6384-4556-ad1a-c2d27f96e4df
Version: 2
Effective Time: 20110524
 
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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