Label: OLOPATADINE solution/ drops
- NDC Code(s): 70069-017-01
- Packager: Somerset Therapeutics, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 25, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
For external use only
- if solution changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
- to treat contact lens related irritation
- do not touch tip of container to any surface to avoid contamination
- remove contact lenses before use
- wait at least 10 minutes before reinserting contact lenses after use
- do not wear a contact lens if your eye is red
-
DOSAGE & ADMINISTRATION
- adults and children 2 years of age and older:
- put 1 drop in the affected eye(s) twice daily, every 6 to 8 hours, no more than twice 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
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
PRINCIPAL DISPLAY PANEL
NDC 70069-017-01
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
Antihistamine and Redness Reliever
TWICE DAILY RELIEF
Eye Allergy Itch & Redness Relief
Sterile
5 mL (0.017 FL OZ)
Original Prescription Strength
NDC 70069-017-01
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%
Antihistamine and Redness Reliever
TWICE DAILY RELIEF
Eye Allergy Itch & Redness Relief
TWICE DAILY
Works in Minutes
Relief from Allergens:
• Pet Dander
• Pollen
• Grass
• Ragweed
Sterile
5 mL (0.017 FL OZ
-
INGREDIENTS AND APPEARANCE
OLOPATADINE
olopatadine solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70069-017 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM CHLORIDE (UNII: 451W47IQ8X) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70069-017-01 1 in 1 CARTON 04/15/2024 1 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 ANDA206306 04/15/2024 Labeler - Somerset Therapeutics, LLC (079947873) Registrant - Somerset Therapeutics, LLC (079947873) Establishment Name Address ID/FEI Business Operations Somerset Therapeutics Limited 677236695 ANALYSIS(70069-017) , LABEL(70069-017) , PACK(70069-017) , MANUFACTURE(70069-017)