Label: PREMIER VALUE STERILE EYE DROPS- dextran 70 polyethylene glycol 400 povidone tetrahydrozoline hci solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-449-00 - Packager: Chain Drug Consortium, LLC
- 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 23, 2014
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ACTIVE INGREDIENT
Active Ingredients Purpose
Dextran 70 0.1%........................................... Lubricant
Polyethylene glycol 400 1%............................. Lubricant
Povidone 1%................................................. Lubricant
Tetrahydrozoline HCI 0.05%............................ Redness Reliever
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREMIER VALUE STERILE EYE DROPS
dextran 70 polyethylene glycol 400 povidone tetrahydrozoline hci solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-449 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70 .001 mg in 1 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 .01 mg in 1 mL POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE .01 mg in 1 mL TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE .0005 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORATE (UNII: T95DR77GMR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-449-00 1 in 1 BOX 1 15 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 01/23/2014 Labeler - Chain Drug Consortium, LLC (101668460)