Label: CLEAR EYES TRIPLE ACTION- polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquid
- NDC Code(s): 67172-898-01
- 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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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Active ingredients
- Purpose
- Active ingredient
- 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
- overuse may produce increased redness of the eye
- pupils may become enlarged temporarily
- to avoid contamination, do not touch tip to any surface
- Directions
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLEAR EYES TRIPLE ACTION
polyvinyl alcohol and povidone and tetrahydrozoline hydrochloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67172-898 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 mg in 1 mL POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE 6 mg in 1 mL TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) DEXTROSE (UNII: IY9XDZ35W2) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67172-898-01 1 in 1 BOX 03/15/2011 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 03/15/2011 Labeler - Prestige Brands Holdings, Inc. (159655021) Establishment Name Address ID/FEI Business Operations Aspen SVP Pty Ltd 569162139 MANUFACTURE(67172-898)