Label: SOUNDBODY ADVANCED RELIEF- dextarn 70, polyethylene glycol 400, povidone, tetrahydrozoline hci solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-637-15 - 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 November 25, 2014
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ACTIVE INGREDIENT
Active ingredients Purpose
Dextran 70 0.1%.............................................. Lubricant
Polyethylene glycol 400 1%................................ Lubricant
Povidone 1%.................................................... Lubricant
Tetrahydrozoline HCI 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
SOUNDBODY ADVANCED RELIEF
dextarn 70, polyethylene glycol 400, povidone, tetrahydrozoline hci solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-637 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 .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:65923-637-15 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 11/25/2014 Labeler - United Exchange Corp. (840130579)