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Olopatadine hydrochloride

Drug Facts

Approved
Approval ID

cc178825-1a4e-6bca-a00d-aa28d5abe589

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 19, 2025

Manufacturers
FDA

Apotex Corp.

DUNS: 845263701

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Olopatadine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code60505-6221
Application NumberANDA078350
Product Classification
M
Marketing Category
C73584
G
Generic Name
Olopatadine hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 19, 2025
FDA Product Classification

INGREDIENTS (7)

OLOPATADINE HYDROCHLORIDEActive
Quantity: 1 mg in 1 mL
Code: 2XG66W44KF
Classification: ACTIM
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/27/2024

Principal Display Panel

TWICE DAILY RELIEF

Olopatadine HCl Ophthalmic Solution, USP 0.1%

Antihistamine and Redness Reliever

Eye Allergy Itch & Redness Relief

NDC 60505-6221-0

Bottle Label

Carton Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 3/23/2020

Uses

Temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 3/23/2020

Active ingredient** (in each tablet)**

Olopatadine (01.%) (equivalent to olopatadine hydrochloride 0.111%)


OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/12/2020

Purpose

Antihistamine and redness reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 5/12/2020

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

Stop use and ask a doctor if you experience**:**

  • Eye pain
  • Changes in vision
  • Increased redness of the eye
  • Itching worsens or lasts for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/23/2020

Directions

*adults and children 2 years 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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/23/2020

Other information

  • Only for use in the eye
  • Store between 4ºC to 25ºC (39ºF to 77ºF)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 3/23/2020

Inactive ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate (anhydrous), hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water and sodium chloride

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 3/23/2020

Questions?

1-800-706-5575

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