Label: OLOPATADINE HYDROCHLORIDE solution
- NDC Code(s): 0363-0200-40
- Packager: WALGREEN CO.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 11, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if you experience:
- 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
-
adults and children 2 years of age and older:
- Other information
- Inactive ingredients
- Questions?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.1% (5 mL Container Carton)
ORIGINAL PRESCRIPTION STRENGTH
NDC 0363-0200-40
Walgreens
Compare to the active ingredient in
Pataday® Twice Daily Relief††
Eye Allergy Itch
& Redness Relief
Relief
OLOPATADINE HYDROCHLORIDE
OPHTHALMIC SOLUTION USP, 0.1%
ANTIHISTAMINE & REDNESS RELIEVER
TWICE DAILY
• Works in minutes
• Relief from allergens:
pet dander, grass,
pollen & ragweed
• Sterile
5 mL (0.17 FL OZ)
-
INGREDIENTS AND APPEARANCE
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0200 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) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) 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:0363-0200-40 1 in 1 CARTON 07/15/2020 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 ANDA204812 07/15/2020 Labeler - WALGREEN CO. (008965063) Registrant - EUGIA Pharma Specialities Limited (650804896) Establishment Name Address ID/FEI Business Operations Eugia Pharma Specialities Limited 650498244 ANALYSIS(0363-0200) , MANUFACTURE(0363-0200)