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FLORIL TEARS by VITALINE S.A.C.

Medically reviewed on January 8, 2018

Dosage form: solution/ drops
Ingredients: POLYVINYL ALCOHOL 14mL in 1mL, POLYETHYLENE GLYCOL 400 2mg in 1mL
Labeler: VITALINE S.A.C.
NDC Code: 16995-002

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.

Floril TEARS

Active ingredients     Purpose


Polyvinyl Alcohol  1,4%   Lubricant

Polyethylene Glycol 400 0,2% Lubricant

When using this product
  • do not touch the tip of the container to any surface to avoid contamination
  • replace cap after each use
  • remove contact lenses before using

Stop use and ask a doctor if
  • You feel eye pain
  • changes in vision occur
  • condition worsens or lasts more than 72 hours

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
  • Put 1 to 2 drops in the affected eyes up to times daily.

Other information

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Uses
  • temporary relief of eye dryness and redness due to insufficient production of tears.
  • prevents further irritation.
FLORIL TEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16995-002
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL14 mL  in 1 mL
POLYETHYLENE GLYCOL 400 (POLYETHYLENE GLYCOL 400) POLYETHYLENE GLYCOL 4002 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
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)

 
VITALINE S.A.C.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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