Label: PREMIER VALUE ORIGINAL- tetrahydrozoline hydrochloride solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-448-00 - 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 5, 2015
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- ACTIVE INGREDIENT
- 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 ORIGINAL
tetrahydrozoline hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-448 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 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:68016-448-00 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 01/27/2014 Labeler - Chain Drug Consortium, LLC (101668460)