FLORIL TEARS - polyvinyl alcohol  solution/ drops 
VITALINE S.A.C.

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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Active ingredients     Purpose


Polyvinyl Alcohol  1,4%   Lubricant

 

When using this product

Stop use and ask a doctor if

Keep our of reach of children.

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

Inactive ingredients

Benzalkonium chloride, dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, polysorbate 80, sodium chloride, polyethylene glycol 300, purified water.

WARNINGS

For external use only.

Do not use if the solution changes color or become cloudy.

Directions

Other information

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Uses

Floril Tears BoxEnter section text here

FLORIL TEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16995-004
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) 2 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16995-004-013 mL in 1 BOTTLE, DROPPER
2NDC:16995-004-0210 mL in 1 BOTTLE, DROPPER
3NDC:16995-004-0315 mL in 1 BOTTLE, DROPPER
4NDC:16995-004-0430 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/10/2005
Labeler - VITALINE S.A.C. (954343687)

Revised: 6/2010
Document Id: 94f2f212-eba2-47a6-96ac-9f9639e2a09d
Set id: 8101c006-0b47-4484-8760-a959764f555c
Version: 1
Effective Time: 20100622
 
VITALINE S.A.C.