LEADER ULTRA LUBRICATING EYE DROPS- polyethylene glycol 400, propylene glycol solution/ drops 
Cardinal Health

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Leader Ultra Lubricating Eye Drops (PLD)

Active ingredients

Polyethylene glycol 400  0.4%
Propylene glycol   0.3%

Purpose

Polyethylene glycol 400............. Lubricant
Propylene glycol............ Lubricant

Uses
• for the temporary relief of burning and irritation due to dryness of the eye

Warnings
For external use only

Do not use
• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

When using this product
• do not touch the 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(s) gets worse or lasts more than 72 hours

Keep out of reach of children
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) as needed
• Children under 6 years of age: ask a doctor

Other information

Inactive ingredients

Aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sorbitol

Single15 ml size

twin size

LEADER ULTRA LUBRICATING EYE DROPS 
polyethylene glycol 400, propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0457
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.4 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0457-11 in 1 BOX02/19/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:70000-0457-22 in 1 BOX04/30/2019
215 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 DrugM01802/19/2019
Labeler - Cardinal Health (063997360)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceuticals, Inc.174450460manufacture(70000-0457) , pack(70000-0457) , label(70000-0457)

Revised: 12/2023
Document Id: 0d37f259-8846-1554-e063-6294a90a639a
Set id: d7f011a2-05ba-47c3-9519-d31602e105c7
Version: 5
Effective Time: 20231223
 
Cardinal Health