Label: OLOPATADINE HYDROCHLORIDE solution

  • NDC Code(s): 16571-882-05
  • Packager: Rising Pharma Holdings, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 4, 2025

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  • ACTIVE INGREDIENT(S)

    Olopatadine (0.1%) (equivalent to olopatadine hydrochloride USP, 0.111%) 

  • PURPOSE

    Antihistamine and redness reliever

  • USE(S)

    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 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.

  • 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°C to 25°C (39°F to 77°F) 

  • Inactive ingredients

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

  • Questions?

    Contact Rising Pharma Holdings, Inc. at 1-844-474-7464

  • PRINCIPAL DISPLAY PANEL

    Rising                                  NDC 16571-882-05

    Olopatadine Hydrochloride Ophthalmic Solution, USP 0.1%

    Antihistamine and Redness Reliever

    NOW AVAILABLE without a prescription
    TWICE DAILY 

    Eye Allergy Itch & Redness Relief

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

    5 mL (0.17 FL OZ)                    STERILE

    carton-label.jpg

    Rising                            NDC 16571-882-05

    Olopatadine Hydrochloride Ophthalmic Solution, USP
    0.1%
    Antihistamine and Redness Reliever
    Eye Allergy Itch & Redness Relief
    TWICE DAILY
    5 mL (0.17 FL OZ)
    STERILE

    container-label.jpg

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-882
    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
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16571-882-051 in 1 CARTON05/01/2025
    15 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20439205/01/2025
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Micro Labs Limited677600482ANALYSIS(16571-882) , LABEL(16571-882) , MANUFACTURE(16571-882) , PACK(16571-882)
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