LEADER ORIGINAL EYE DROPS- tetrahydrozoline hcl solution/ drops 
Cardinal Health

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Leader Original Eye Drops 15mL (PLD)

Active ingredient

Tetrahydrozoline HCL 0.05%

Purpose

Redness reliever

Uses

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

If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of chlidren

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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

Other information

store at 15-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

1-888-527-4276

Leader Original Eye Drops 15mL

Leader Original Eye Drops 15mL

LEADER ORIGINAL EYE DROPS 
tetrahydrozoline hcl solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0454
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE0.05 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0454-11 in 1 CARTON02/19/2019
115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01802/19/2019
Labeler - Cardinal Health (063997360)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceuticals, Inc.174450460manufacture(70000-0454) , pack(70000-0454) , label(70000-0454)

Revised: 12/2023
Document Id: 0d37dad1-2199-7c25-e063-6394a90a7eb7
Set id: aec2ef95-0b9b-48dd-8809-73d19e309e4f
Version: 6
Effective Time: 20231223
 
Cardinal Health