Label: ARTIFICIAL TEARS LUBRICANT EYE- polyvinyl alcohol and povidone liquid
- NDC Code(s): 67172-181-01
- Packager: Prestige Brands Holdings, Inc.
- 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 September 11, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
When using this product:
- to avoid contamination, do not touch tip to any surface.
- replace cap after using.
- to avoid contamination, do not touch tip to any surface.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARTIFICIAL TEARS LUBRICANT EYE
polyvinyl alcohol and povidone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-181 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED 5.0 mg in 1 mL POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE 6.0 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) DEXTROSE (UNII: IY9XDZ35W2) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-181-01 1 in 1 BOX 06/01/2012 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part349 06/01/2012 Labeler - Prestige Brands Holdings, Inc. (159655021)