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LEADER ADVANCED FORMULA EYE DROPS

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: HANLIM PHARM. CO., LTD.
NDC Code: 11716-1104

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

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LEADER ADVANCED FORMULA EYE DROPS 
dextran 70 solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-1104
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:11716-1104-11 BOTTLE (BOTTLE) in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34905/06/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)

 
HANLIM PHARM. CO., LTD.

Medically reviewed on May 7, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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