TOPCARE HEALTH LUBRICANT EYE DROPS- polyethylene glycol 400, propylene glycol solution 
Topco Assoc LLC

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Topcare Health Lubricant 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 right away

Directions

Other information

Inactive ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride

carton

TOPCARE HEALTH LUBRICANT EYE DROPS 
polyethylene glycol 400, propylene glycol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-978
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.3 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4000.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ZINC CHLORIDE (UNII: 86Q357L16B)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
BORIC ACID (UNII: R57ZHV85D4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-978-011 in 1 CARTON02/07/2020
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 DrugM01802/07/2020
Labeler - Topco Assoc LLC (006935977)
Registrant - K.C. Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
K.C. Pharmaceuticals, Inc.174450460manufacture(36800-978) , pack(36800-978) , label(36800-978)

Revised: 12/2023
Document Id: 0cfa87ca-f1d7-c578-e063-6394a90a7626
Set id: 9c6284f9-00bb-37b5-e053-2a95a90ae2ee
Version: 3
Effective Time: 20231220
 
Topco Assoc LLC