Label: FLORIL TEARS- polyvinyl alcohol solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 16995-002-01, 16995-002-02, 16995-002-03, 16995-002-04 - Packager: VITALINE S.A.C.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated January 7, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Floril TEARS
- ACTIVE INGREDIENT
- When using this product
- Stop use and ask a doctor if
- Keep our of reach of children.
- Inactive ingredients
- WARNINGS
- Directions
- Other information
- Uses
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INGREDIENTS AND APPEARANCE
FLORIL TEARS
polyvinyl alcohol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16995-002 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 mL in 1 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16995-002-01 3 mL in 1 BOTTLE, DROPPER 2 NDC:16995-002-02 10 mL in 1 BOTTLE, DROPPER 3 NDC:16995-002-03 15 mL in 1 BOTTLE, DROPPER 4 NDC:16995-002-04 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)
