FLORIL TEARS- polyvinyl alcohol solution/ drops

FLORIL TEARS by

Drug Labeling and Warnings

FLORIL TEARS by is a Otc medication manufactured, distributed, or labeled by VITALINE S.A.C.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients     Purpose

Polyvinyl Alcohol  1,4%   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, polyethylene glycol 300, 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

Enter section text here

Uses

• temporary relief of eye dryness and redness due to insufficient production of tears.
• prevents further irritation.
  

PRINCIPAL DISPLAY PANEL

Enter section text here

INGREDIENTS AND APPEARANCE

FLORIL TEARS 
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 16995-004
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	14 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)	2 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 16995-004-01	3 mL in 1 BOTTLE, DROPPER
2	NDC: 16995-004-02	10 mL in 1 BOTTLE, DROPPER
3	NDC: 16995-004-03	15 mL in 1 BOTTLE, DROPPER
4	NDC: 16995-004-04	30 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/10/2005

Labeler - VITALINE S.A.C. (954343687)