Label: PATADAY TWICE A DAY RELIEF- olopatadine hydrochloride solution

  • NDC Code(s): 0065-4274-01
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated December 15, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Olopatadine (0.1%).
    (equivalent to olopatadine hydrochloride 0.111%)
    Antihistamine and Redness Reliever
  • INDICATIONS & USAGE

    Use temporarily relieves itchy and red eyes due to pollen, ragweed, grass, animal hair and dander

  • WARNINGS

    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

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    • only for use in the eye
    • store between 4°-25°C (39°-77°F)
  • Inactive ingredients

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

  • Questions?

    In the U.S., call 1-800-757-9195 or email alcon.medinfo@alcon.com

    Alcon Laboratories, Inc.
    6201 South Freeway
    Fort Worth, Texas 76134
    Country of Origin: Japan

    NDC: 0065-4274-01
    9017919-1219

  • PRINCIPAL DISPLAY PANEL

    Original Prescription Strength

    Pataday®
    TWICE DAILY RELIEF
    Olopatadine hydrochloride
    ophthalmic solution 0.1%
    Antihistamine and Redness Reliever

    Eye Allergy Itch & Redness Relief
    TWICE DAILY

    Works in Minutes
    Relief from Allergens:
       • Pet Dander
       • Pollen
        • Grass
       • Ragweed

    STERILE
    5 mL (0.17 FL OZ) 

    Alcon  

    Pataday®

    TWICE DAILY RELIEF  
    Eye Allergy Itch & Redness Relief
    Works in Minutes

    For Ages 2 and Older
    30 DAY SUPPLY 

    TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. 

    ________Fill Line________ 

    Do not use if seal is damaged or missing at time of purchase.  

    ACTUAL SIZE 

    Alcon Laboratories, Inc.
    6201 South Freeway
    Fort Worth, Texas 76134
    Country of Origin: Japan 
     

    NDC: 0065-4274-01   
    300036779-0320

    LOT:     EXP.:

    carton

    Pataday®
    TWICE DAILY RELIEF
    Olopatadine hydrochloride
    ophthalmic solution 0.1%
    Antihistamine and Redness Reliever
    Eye Allergy Itch & Redness Relief

    5 mL (0.17 FL OZ)
    STERILE

    Only for use in the eye.
    Store between 4° – 25° C (39° – 77° F)

    TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase. 

    Alcon Laboratories, Inc.
    6201 South Freeway
    Fort Worth, TX 76134 

    LOT:          EXP.:

    H15723-1219 

    label
  • INGREDIENTS AND APPEARANCE
    PATADAY TWICE A DAY RELIEF 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-4274
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Olopatadine Hydrochloride (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM) Olopatadine1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Phosphate, Dibasic, Unspecified Form (UNII: GR686LBA74)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-4274-011 in 1 CARTON02/25/2020
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02068802/25/2020
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-4274)