LEADER ARTIFICIAL TEARS 15 ML- polyvinyl alcohol, povidone solution/ drops 
Cardinal Health

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Leader Artificial Tears 15mL (PLD)

Active Ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purposes

Lubricant

Lubricant

Uses

Warnings

For external use only

Do not use this product if

  • solution changes color or becomes cloudy

When using this product

  • remove contact lens before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed.

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

Keep out of the reach of children.

if accidentally swallowed, get medical help or contact Poison Control Center (1-800-222-1222) immediately.

Directions

Other Information

Inactive Ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, sodium phosphate monobasic

Questions or comments?

Call 1-888-527-4276

Leader Artificial Tears 15mL

Leader Artificial Tears 15 mL

LEADER ARTIFICIAL TEARS 15 ML 
polyvinyl alcohol, povidone solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0011
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED0.5 g  in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE0.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
DEXTROSE (UNII: IY9XDZ35W2)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0011-11 in 1 BOX07/03/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01807/03/2019
Labeler - Cardinal Health (063997360)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceuticals, Inc.174450460manufacture(70000-0011) , pack(70000-0011) , label(70000-0011)

Revised: 12/2023
Document Id: 0d376274-1a79-5fbc-e063-6394a90a2cf2
Set id: 8cccc589-3a8e-baad-e053-2a95a90ab8c7
Version: 4
Effective Time: 20231223
 
Cardinal Health