LEADER ADVANCED FORMULA

Dosage form: solution
Ingredients: DEXTRAN 70 0.001mL in 1mL, POLYETHYLENE GLYCOL 400 0.01mL in 1mL, POVIDONE 0.01mL in 1mL, TETRAHYDROZOLINE HYDROCHLORIDE 0.0005mL in 1mL
Labeler: CARDINAL HEALTH
NDC Code: 37205-224

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                                                                Purpose

Dextran 70 0.1%.................................................................Lubricant

Polyethylene glycol 400 1%.................................................Lubricant

Povidone 1%......................................................................Lubricant

Tetrahydrozoline HCL 0.05%................................................Redness reliever

Uses

  • for the relief of redness of the eyes due to minor eye irritations
  • for use as a protectant against further irritation or to relieve dryness of the eye


Warnings

Ask a doctor before use if you have narrow angle glaucoma

When using this product

  • pupils may become enlarged temporarily
  • overuse may cause more eye redness
  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • 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 lasts
  • condition worsens or lasts more than 72 hours

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

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

Directions

  • put 1 to 2 drops in the affected eye(s) up to 4 times daily
  • children under 6 years of age: ask a doctor

Other information

some users may experience a brief tingling sensation

store at 15o to 25oC (59o to 77oF)

Inactive ingredients:

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

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 3256021

www.myleader.com

1-800-200-6313

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LEADER ADVANCED FORMULA 
dextran70, polyethylene glycol, povidone, tetrahydrozoline hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-224
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTRAN 70 (DEXTRAN 70) DEXTRAN 700.001 mL  in 1 mL
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 4000.01 mL  in 1 mL
POVIDONE (POVIDONE) POVIDONE0.01 mL  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (TETRAHYDROZOLINE) TETRAHYDROZOLINE HYDROCHLORIDE0.0005 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORIC ACID 
EDETATE DISODIUM 
WATER 
SODIUM CHLORIDE 
SODIUM BORATE 
Packaging
#Item CodePackage Description
1NDC:37205-224-051 BOTTLE (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/04/2012
Labeler - CARDINAL HEALTH (097537435)

Revised: 01/2012
 
CARDINAL HEALTH

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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