Label: OLOPATADINE HYDROCHLORIDE solution
- NDC Code(s): 76162-044-39
- Packager: TOPCO ASSOCIATES LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 14, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if you experience:
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)
+ TopCare® NDC 76162-044-39
health
COMPARE TO PATADAY® ONCE DAILY
RELIEF ACTIVE INGREDIENT*
Olopatadine Hydrochloride
Ophthalmic Solution, USP 0.2%
Eye Allergy
Itch Relief
Antihistamine
Works in Minutes
Relief from Allergens:
• Pet Dander • Pollen
• Grass • Ragweed
ONCE
DAILY
STERILE 0.085 FL (2.5 mL)
-
INGREDIENTS AND APPEARANCE
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-044 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-044-39 1 in 1 CARTON 07/15/2020 1 2.5 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 ANDA ANDA209995 07/15/2020 Labeler - TOPCO ASSOCIATES LLC (006935977) Establishment Name Address ID/FEI Business Operations EUGIA PHARMA SPECIALITIES LIMITED 650498244 ANALYSIS(76162-044) , MANUFACTURE(76162-044) , PACK(76162-044)