Label: EYE ALLERGY ITCH AND REDNESS RELIEF- olopatadine hydrochloride ophthalmic solution/ drops
- NDC Code(s): 70000-0054-1
- Packager: LEADER/ Cardinal Health 110, Inc.
- This is a repackaged label.
- Source NDC Code(s): 43598-765
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 15, 2021
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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 DOCTOR IF
- KEEP OUT 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 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
-
INGREDIENTS AND APPEARANCE
EYE ALLERGY ITCH AND REDNESS RELIEF
olopatadine hydrochloride ophthalmic solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0054(NDC:43598-765) 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 (UNII: GR686LBA74) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0054-1 1 in 1 CARTON 01/15/2021 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 ANDA209619 01/15/2021 Labeler - LEADER/ Cardinal Health 110, Inc. (063997360)