Label: OLOPATADINE- olopatadine hydrochloride solution/ drops
- NDC Code(s): 17478-308-05
- Packager: Akorn
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 3, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
Do not use
- if solution changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
- to treat contact lens related irritation
When using the product
- 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
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Directions
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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
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adults and children 2 years of age and older:
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
PRINCIPAL DISPLAY PANEL
Principal Display Panel Text for Carton Label:
Original NDC 17478-308-05
Prescription
Strength Akorn logo
Olopatadine
HCl Ophthalmic
Solution, USP
0.1%
Antihistamine and Redness Reliever
Eye Allergy Itch & Redness Relief
Works in Minutes
Relief from Allergens:
• Pet Dander
• Pollen
• Grass
• Ragweed
TWICE DAILY
STERILE
5 mL (0.17 FL OZ)
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INGREDIENTS AND APPEARANCE
OLOPATADINE
olopatadine hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17478-308 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 benzalkonium chloride (UNII: F5UM2KM3W7) sodium phosphate, dibasic, unspecified form (UNII: GR686LBA74) hydrochloric acid (UNII: QTT17582CB) sodium hydroxide (UNII: 55X04QC32I) sodium chloride (UNII: 451W47IQ8X) water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17478-308-05 1 in 1 CARTON 09/01/2021 1 5 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 ANDA ANDA204532 09/01/2021 Labeler - Akorn (117696770) Registrant - AKORN OPERATING COMPANY LLC (117693100) Establishment Name Address ID/FEI Business Operations Akorn 117696840 LABEL(17478-308) , MANUFACTURE(17478-308) , PACK(17478-308) , ANALYSIS(17478-308) , STERILIZE(17478-308)