NDC | 55315-118-15 |
Set ID | e34d24da-9f44-4bbb-9b1d-2aa175f578f8 |
Category | HUMAN OTC DRUG LABEL |
Packager | FREDS, INC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART349 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Dextran 70 0.1%..........................................................Lubricant
Polyethylene Glycol 400 1% ........................................Lubricant
Povidone 1% ..............................................................Lubricant
Tetrahydrozoline HCL 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
FREDS ADVANCED EYE DROPS
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-118 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70 1 mg in 1 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 10 mg in 1 mL POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE 10 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) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BORATE (UNII: 91MBZ8H3QO) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-118-15 1 in 1 CARTON 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part349 10/15/2012 Labeler - FREDS, INC (005866116)