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

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Leader Preservative-Free 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 of the eye 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
• do not reuse

  • once opened, discard

Stop use and ask a doctor if
• you feel eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

If pregnant or breast-feeding, ask a health professional before use.

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

Other information

Inactive ingredients

boric acid, hypromellose, potassium chloride, purified water, sodium chloride.  May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?  Call 1-888-527-4276

carton

LEADER PRESERVATIVE-FREE ULTRA LUBRICATING EYE DROPS 
polyethylene glycol 400, propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0501
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
BORIC ACID (UNII: R57ZHV85D4)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0501-125 in 1 BOX04/30/2019
10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01804/30/2019
Labeler - Cardinal Health (063997360)
Registrant - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
KC Pharmaceuticals, Inc.174450460pack(70000-0501) , label(70000-0501)
Establishment
NameAddressID/FEIBusiness Operations
Unimed689852052manufacture(70000-0501)

Revised: 12/2023
Document Id: 0d37f259-8847-1554-e063-6294a90a639a
Set id: 2a2aa620-ca63-4698-88fd-fc263b8fa0d1
Version: 7
Effective Time: 20231223
 
Cardinal Health