Label: OLOPATADINE HYDROCHLORIDE solution/ drops
- NDC Code(s): 60505-6222-1, 60505-6222-2, 60505-6222-3
- Packager: Apotex Corp.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated September 27, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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 this 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
- Directions
- Other information
- Inactive ingredients
- Questions?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60505-6222 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) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60505-6222-2 1 in 1 CARTON 10/06/2022 1 NDC:60505-6222-1 2.5 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:60505-6222-3 2 in 1 CARTON 10/06/2022 2 2.5 mL in 1 BOTTLE, PLASTIC; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA090918 10/06/2022 Labeler - Apotex Corp. (845263701)