Label: OLOPATADINE HCL solution/ drops

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 16, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Olopatadine (0.1%)

    (equivalent to olopatadine hydrochloride, USP 0.111%)

  • Purpose

    Antihistamine and redness reliever

  • Uses

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

  • 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 our 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 opthalmic 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 (to adjust pH), sodium chloride and water for injection

  • Questions?

    Call 1-866-747-7365

  • Principle Display Panel

    Manufactured for:

    SOLA Pharmaceuticals LLC,

    Baton Rouge, LA 70810

    Made in India

    Code No: DD/DRUGS/DD/292

    Olopatadine Hcl Opthalmic Solution 0.1% Bottle Label:

    Bottle Label

    Olopatadine Hcl Opthalmic Solution 0.1% Carton Label:

    Carton Label

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HCL 
    olopatadine hcl solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70512-520
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE HYDROCHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70512-520-051 in 1 CARTON07/05/2022
    15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20315207/05/2022
    Labeler - Sola Pharmaceuticals (080121345)