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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Floril TEARS

Carton of Floril Tear

Active ingredients     Purpose


Polyvinyl Alcohol  1,4%   Lubricant

Polyethylene Glycol 400 0,2% 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, purified water.

WARNINGS

For external use only.

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

Directions

Other information

Enter section text here

Uses

FLORIL TEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16995-002
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL14 mL  in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 4002 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16995-002-013 mL in 1 BOTTLE, DROPPER
2NDC:16995-002-0210 mL in 1 BOTTLE, DROPPER
3NDC:16995-002-0315 mL in 1 BOTTLE, DROPPER
4NDC:16995-002-0430 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: 1/2010
Document Id: 6becdef5-06d3-4a24-b46b-c8bb682a1339
Set id: 22125054-98e6-47de-a56f-91ca54c318c4
Version: 2
Effective Time: 20100107
 
VITALINE S.A.C.