Leader advanced formula solution

Otc - active ingredient section

Active ingredients Purpose

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

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

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

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

Otc - purpose section

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 section

Warnings

Ask a doctor before use if you have narrow angle glaucoma

Otc - when using section

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

Otc - stop use section

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

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,

ask a health professional before use.

Otc - keep out of reach of children section

Keep out of the reach of children.

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

Indications & usage section

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

Storage and handling section

Other information

some users may experience a brief tingling sensation

store at 15 oto 25 oC (59 oto 77 oF)

Inactive ingredient section

Inactive ingredients:

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

Dosage & administration section

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

CIN 3256021

www.myleader.com

1-800-200-6313

Ingredients and appearance - Product information

Leader advanced formula solution- Dextran70, polyethylene glycol, povidone, tetrahydrozoline hcl

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 37205-224
Route of Administration Ophthalmic

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextran 70 ( UNII: 7SA290YK68)( Dextran 70 - UNII: 7SA290YK68 ) 1 mgin 1 mL
Polyethylene glycol 400 ( UNII: B697894SGQ)( Polyethylene glycol 400 - UNII: B697894SGQ ) 10 mgin 1 mL
Povidones ( UNII: FZ989GH94E)( Povidone - UNII: FZ989GH94E ) 10 mgin 1 mL
Tetrahydrozoline hydrochloride ( UNII: 0YZT43HS7D)( Tetrahydrozoline - UNII: S9U025Y077 ) 0.5 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Benzalkonium chloride ( UNII: F5UM2KM3W7)
Boric acid ( UNII: R57ZHV85D4)
Edetate disodium ( UNII: 7FLD91C86K)
Water ( UNII: 059QF0KO0R)
Sodium chloride ( UNII: 451W47IQ8X)
Sodium borate ( UNII: 91MBZ8H3QO)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part349 USA

Labeler - CARDINAL HEALTH( 097537435)

Package label.principal display panel