GOODSENSE ARTIFICIAL TEARS - polyvinyl alcohol solution 
HANLIM PHARM. CO., LTD.

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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Drug Facts

Uses

Warnings

For external use only.  Do not use if solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Sodium Phosphate (Mono- and Dibasic)

image of carton labelEnter section text here

GOODSENSE ARTIFICIAL TEARS 
polyvinyl alcohol solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11716-0001
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL5 mg  in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
DEXTROSE (UNII: IY9XDZ35W2)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
WATER (UNII: 059QF0KO0R)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM PHOSPHATE (UNII: SE337SVY37)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11716-0001-61 in 1 CARTON
115 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/22/2010
Labeler - HANLIM PHARM. CO., LTD. (687986034)

Revised: 7/2010
Document Id: 00637064-ea23-451f-be9b-73b1f5dcf896
Set id: b064a62d-7e2d-4b1a-a602-74728bb7d7cf
Version: 2
Effective Time: 20100722
 
HANLIM PHARM. CO., LTD.