NDC | 50804-019-05 |
Set ID | ada3a039-78ba-4f11-9291-9385d028c577 |
Category | HUMAN OTC DRUG LABEL |
Packager | Geiss, Destin & Dunn, 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 glycrol 400 1%..............................Lubricant
Povidone 1%....................................................Lubricant
Tetrahydrozoline HCI 0.05%..............................Redness reliever
- PURPOSE
- WARNINGS
- ASK DOCTOR
- 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
GOODSENSE ADVANCED RELIEF EYE
dextran 70, polyethylene glycol 400, povidone, and tetrahydrozoline hci solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50804-019 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) WATER (UNII: 059QF0KO0R) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50804-019-05 1 in 1 BOX 03/24/2016 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 03/24/2016 Labeler - Geiss, Destin & Dunn, Inc. (076059836)