Eye Drops Extra

Dosage form: solution/ drops
Ingredients: TETRAHYDROZOLINE HYDROCHLORIDE 0.5mg in 1mL, POLYETHYLENE GLYCOL 400 10mg in 1mL
Labeler: KC Pharmaceuticals, Inc.
NDC Code: 55651-012

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 1%

Tetrahydrozoline HCl 0.05%

Purpose

Polyethylene glycol 400 - Eye lubricant

Tetrahydrozoline HCl - Redness reliever

Keep out of reach of children.

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

Uses
  • relieves redness of the eye due to minor eye irritations
  • as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

When using this product

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface.  Replace cap after using.
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

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

Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily.

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, and sodium chloride

Other information
  • Tamper Evident.  Do not use this product if imprinted neckband is missing or broken.
  • 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

EDXT

EYE DROPS EXTRA 
tetrahydrozoline hydrochloride, polyethylene glycol 400 solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-012
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 40010 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE0.1 mg  in 1 mL
BORIC ACID 
EDETATE DISODIUM 
WATER 
SODIUM BORATE 
SODIUM CHLORIDE 
Packaging
#Item CodePackage Description
1NDC:55651-012-011 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 finalpart34912/09/2003
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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