Label: OLOPATADINE HCL solution/ drops
- NDC Code(s): 70512-520-05
- Packager: Sola Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 16, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if you experience:
- Keep our of reach of children.
-
Directions
- 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 opthalmic 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?
- Principle Display Panel
-
INGREDIENTS AND APPEARANCE
OLOPATADINE HCL
olopatadine hcl solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70512-520 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) HYDROCHLORIC ACID (UNII: QTT17582CB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70512-520-05 1 in 1 CARTON 07/05/2022 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 ANDA203152 07/05/2022 Labeler - Sola Pharmaceuticals (080121345)