LEADER LUBRICANT EYE DROPS 30CT- polyethylene glycol 400, propylene glycol liquid 
KC Pharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Leader Lubricant Eye Drops 30ct

Active ingredients

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purposes

Lubricant

Lubricant

Use

Warnings

For external use only

Do not use

  • if the solution changes color or becomes cloudy
  • if you are sensative to any ingredient in this product

When using this product

  • do not touch 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 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

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 LUBRICANT EYE DROPS 30CT 
polyethylene glycol 400, propylene glycol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55651-017
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL, UNSPECIFIED - UNII:3WJQ0SDW1A) 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
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
BORIC ACID (UNII: R57ZHV85D4)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55651-017-0130 in 1 BOX07/18/2019
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 finalpart34907/18/2019
Labeler - KC Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
K.C. Pharmaceuticals, Inc.174450460pack(55651-017) , label(55651-017)
Establishment
NameAddressID/FEIBusiness Operations
Unimed689852052manufacture(55651-017)

Revised: 2/2023
Document Id: f5462642-b431-d2cc-e053-2995a90ae7f5
Set id: f5462689-9722-5f00-e053-2a95a90a8ed8
Version: 1
Effective Time: 20230222
 
KC Pharmaceuticals, Inc.