Label: LIQUITEARS- polyvinyl alcohol solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 52959-041-00 - Packager: H.J. Harkins Company, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0904-5017
- 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 March 9, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
- Do not use if solution changes color or becomes cloudy
When using this product
- do not touch tip of container to any surface to avoid contamination
- replace cap after use
Stop use and ask a doctor if
- you experience eye pain, changes in vision, continued redness or irritation of the eye
- condition worsens or persists for more than 72 hours
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions ?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
LIQUITEARS
polyvinyl alcohol solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52959-041(NDC:0904-5017) 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 SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52959-041-00 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 12/09/2011 Labeler - H.J. Harkins Company, Inc. (147681894) Registrant - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Business Operations Bausch & Lomb Incorporated 807927397 MANUFACTURE