Label: CORE VALUES EYE DROPS ADVANCED RELIEF- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride solution/ drops
- NDC Code(s): 63940-344-01
- Packager: Liberty Procurement Co., Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 23, 2023
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- Official Label (Printer Friendly)
- Active Ingredients
- Purposes
- Uses
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Warnings
For external use only
When using this product
- pupils may become enlarged temporarily
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
- if solution changes color or becomes cloudy,do not use
- overuse may produce increased redness of the eye
- remove contact lens before using
- Directions
- Other information
- Inactive ingredients
- Core Values Eye Drops Advanced Relief
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INGREDIENTS AND APPEARANCE
CORE VALUES EYE DROPS ADVANCED RELIEF
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-344 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68) DEXTRAN 70 0.1 g in 100 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 1 g in 100 mL POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE 1 g in 100 mL TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077) TETRAHYDROZOLINE HYDROCHLORIDE 0.05 g in 100 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:63940-344-01 1 in 1 BOX 03/19/2023 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 Drug M018 03/19/2023 Labeler - Liberty Procurement Co., Inc. (804085293) Registrant - K.C. Pharmaceuticals, Inc. (174450460) Establishment Name Address ID/FEI Business Operations KC Pharmaceuticals, Inc 174450460 manufacture(63940-344) , label(63940-344) , pack(63940-344)