NDC | 65923-511-15 |
Set ID | 716d2f37-ae19-42b1-9d85-d07777dedaed |
Category | HUMAN OTC DRUG LABEL |
Packager | United Exchange Corp |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART349 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Tetrahydrozoline HCl 0.05%.............................................................Redness reliever
Dextran 70 0.1%............................................................................Lubricant
Polyethylene glycol 400 1%.............................................................Lubricant
Povidone 1%.................................................................................Lubricant
- PURPOSE
- WARNINGS
- ASK DOCTOR
- PURPOSE
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FAMILY CARE ADVANCED FORMULA EYE
tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400, povidone solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-511 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.5 mg in 1 mL 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 Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM BORATE (UNII: 91MBZ8H3QO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-511-15 1 in 1 CARTON 11/25/2014 1 15 mL in 1 BOTTLE; 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 11/25/2014 Labeler - United Exchange Corp (840130579)