Label: OLOPATADINE HYDROCHLORIDE solution
- NDC Code(s): 16571-861-25
- Packager: Rising Pharma Holdings, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 4, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT(S)
- PURPOSE
- USE(S)
- WARNINGS
- DO NOT USE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
▪ adults and children 2 years of age and older:
▪ put 1 drop in the affected eyes(s) once daily, no more than once per day
▪ if using other ophthalmic products while using this product, wait at least 5 minutes between each product
▪ replace cap after each use
▪ children under 2 years of age: consult a doctor - Other information
- Inactive ingredients
- Questions?
-
PRINCIPAL DISPLAY PANEL
Rising NDC 16571-861-25
Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2%ONCE DAILY RELIEF Antihistamine
NOW AVAILABLE without a prescription
ONCE DAILYEye Allergy Itch Relief
Works in Minutes
Relief from Allergens:
•Pet Dander•Pollen
•Grass
•Ragweed
2.5 mL STERILE
Rising NDC 16571-861-25
Olopatadine Hydrochloride Ophthalmic Solution, USP
0.2%
ONCE DAILY RELIEF Antihistamine
Eye Allergy Itch Relief
ONCE DAILY
2.5 mL
STERILE
-
INGREDIENTS AND APPEARANCE
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16571-861 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) POVIDONE K30 (UNII: U725QWY32X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16571-861-25 1 in 1 CARTON 05/01/2025 1 2.5 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA204620 05/01/2025 Labeler - Rising Pharma Holdings, Inc. (116880195) Establishment Name Address ID/FEI Business Operations Micro Labs Limited 677600482 ANALYSIS(16571-861) , LABEL(16571-861) , MANUFACTURE(16571-861) , PACK(16571-861)
