- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
EYE DROPS REGULAR
tetrahydrozoline hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0102 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 WATER (UNII: 059QF0KO0R) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM BORATE (UNII: 91MBZ8H3QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62011-0102-1 1 in 1 CARTON 03/01/2012 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 final part349 03/01/2012 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - KC Pharmaceuticals, Inc. (174450460) Establishment Name Address ID/FEI Business Operations KC Pharmaceuticals, Inc. 174450460 manufacture(62011-0102) , pack(62011-0102) , label(62011-0102)