ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution 
NuCare 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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Good Sense Artificial Tears PLD

Active ingredients

Polyvinyl alcohol.....0.5%

Povidone......0.6%

Purposes

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 persists for more than 72 hours

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

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

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

pdp

ARTIFICIAL TEARS 
polyvinyl alcohol, povidone solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-4914(NDC:50804-110)
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
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
DEXTROSE (UNII: IY9XDZ35W2)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68071-4914-515 mL in 1 BOX; Type 0: Not a Combination Product01/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34901/02/2020
Labeler - NuCare Pharmaceuticals,Inc. (010632300)
Establishment
NameAddressID/FEIBusiness Operations
NuCare Pharmaceuticals,Inc.010632300relabel(68071-4914)

Revised: 2/2021
Document Id: bb9f184c-211d-2c45-e053-2a95a90a3563
Set id: 9c1c4911-908e-3c3c-e053-2995a90abcfc
Version: 2
Effective Time: 20210218
 
NuCare Pharmaceuticals,Inc.