Label: LEADER DRY EYE RELIEF EYE DROPS- glycerin, hypromellose, polyethylene glycol 400 solution/ drops
- NDC Code(s): 70000-0502-1, 70000-0502-2
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 23, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
For external use only
When using this product
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
- remove contact lens before using
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Leader Dry Eye Relief Eye Drops 15mL
- Leader Dry Eye Relief Eye Drops 15mL twin pk
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INGREDIENTS AND APPEARANCE
LEADER DRY EYE RELIEF EYE DROPS
glycerin, hypromellose, polyethylene glycol 400 solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0502 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 0.2 g in 100 mL HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED 0.2 g in 100 mL POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ) POLYETHYLENE GLYCOL 400 1 g in 100 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) DEXTROSE (UNII: IY9XDZ35W2) EDETATE DISODIUM (UNII: 7FLD91C86K) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0502-1 1 in 1 CARTON 04/30/2019 1 15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:70000-0502-2 2 in 1 CARTON 04/30/2019 2 15 mL in 1 BOTTLE, PLASTIC; 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 04/30/2019 Labeler - Cardinal Health (063997360) Registrant - KC Pharmaceuticals, Inc. (174450460) Establishment Name Address ID/FEI Business Operations KC Pharmaceuticals, Inc. 174450460 manufacture(70000-0502) , pack(70000-0502) , label(70000-0502)