LEADER RESTORATIVE FORMULA LUBRICANT EYE DROPS- propylene glycol solution/ drops 
Cardinal Health

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Leader Restorative Formula Lubricant Eye Drops (PLD)

Active ingredients

Propylene glycol....0.6%

Purpose

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
• if you are sensitive to any ingredient in this product

When using this product
• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

Stop use and ask a doctor if
• you experience eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persists 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

Other information

Inactive ingredients

Benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions & comments?

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LEADER RESTORATIVE FORMULA LUBRICANT EYE DROPS 
propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0013
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
CASTOR OIL (UNII: D5340Y2I9G)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0013-11 in 1 BOX04/30/2019
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:70000-0013-22 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 DrugM01804/30/2019
Labeler - Cardinal Health (063997360)
Registrant - Daewoo Pharmaceutical Co., Ltd. (689046329)
Establishment
NameAddressID/FEIBusiness Operations
Daewoo Pharmaceutical Co., Ltd.689046329manufacture(70000-0013) , pack(70000-0013) , label(70000-0013)

Revised: 12/2023
Document Id: 0d37718d-85da-696a-e063-6394a90a291e
Set id: 87fef7e4-e5a8-4aad-94d2-f80f34826d97
Version: 4
Effective Time: 20231223
 
Cardinal Health