Label: FAMILY CARE ADVANCED FORMULA EYE- tetrahydrozoline hydrochloride, dextran 70, polyethylene glycol 400, povidone solution/ drops
- NDC Code(s): 65923-511-15
- Packager: United Exchange Corp
- 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 February 18, 2020
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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)