TOPCARE HEALTH ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution 
Topco Associates LLC

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Topcare Artificial Tears (PLD)

Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purpose

Polyvinyl alcohol......................Eye lubricant

Povidone.................................Eye lubricant

Uses

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

Stop use and ask a doctor if you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye or if the condition worsens or perists for more than 72 hours

When using this product

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed
  • remove contact lens before using

Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

Inactive ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic

 carton

TOPCARE HEALTH ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-972
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED0.5 g  in 100 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE0.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
DEXTROSE (UNII: IY9XDZ35W2)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-972-011 in 1 CARTON01/31/2020
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 DrugM01801/31/2020
Labeler - Topco Associates LLC (006935977)
Registrant - K.C. Pharmaceuticals, Inc. (174450460)
Establishment
NameAddressID/FEIBusiness Operations
K.C. Pharmaceuticals, Inc.174450460manufacture(36800-972) , pack(36800-972) , label(36800-972)

Revised: 12/2023
Document Id: 0cfa87ca-f1d5-c578-e063-6394a90a7626
Set id: 9c614c0e-5862-682f-e053-2a95a90abc09
Version: 3
Effective Time: 20231220
 
Topco Associates LLC