Label: OLOPATADINE HYDROCHLORIDE solution
- NDC Code(s): 58602-010-39, 58602-010-41
- Packager: Aurohealth LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated August 28, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Purpose
- Use
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if you experience:
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton)
Healthy LivingTM NDC 58602-010-39
*Compare to the Active Ingredient in
Pataday® Once Daily Relief
NOW AVAILABLE without a prescription
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Antihistamine
Eye Allergy Itch Relief
Works in Minutes
Relief from Allergens: ONCE
• Pet Dander • Pollen DAILY
• Grass • Ragweed STERILE
2.5 mL (0.085 FL OZ)
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL-0.2% (2.5 mL Container Carton) Twin Pack
Twin Pack
Healthy LivingTM NDC 58602-010-41
*Compare to the Active Ingredient in
Pataday® Once Daily Relief
NOW AVAILABLE without a prescription
Olopatadine Hydrochloride
Ophthalmic Solution, USP
0.2%
Antihistamine
Eye Allergy Itch Relief
Works in Minutes
Relief from Allergens: ONCE
• Pet Dander • Pollen DAILY
• Grass • Ragweed STERILE
Two 2.5 mL Bottles
(0.085 FL OZ Each)
-
INGREDIENTS AND APPEARANCE
OLOPATADINE HYDROCHLORIDE
olopatadine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58602-010 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE 2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74) EDETATE DISODIUM (UNII: 7FLD91C86K) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58602-010-39 1 in 1 CARTON 07/15/2020 1 2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 2 NDC:58602-010-41 2 in 1 CARTON 07/15/2020 2 2.5 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 ANDA209995 07/15/2020 Labeler - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations Aurobindo Pharma Limited 650498244 ANALYSIS(58602-010) , MANUFACTURE(58602-010)