Label: OLOPATADINE HYDROCHLORIDE solution

  • NDC Code(s): 16571-861-25
  • 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

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

  • ACTIVE INGREDIENT(S)

    Olopatadine (0.2%) (equivalent to olopatadine hydrochloride 0.222%) 

  • PURPOSE

    Antihistamine 

  • USE(S)

    temporarily relieves itchy 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 eyes(s) once daily, no more than once 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

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

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Rising                                  NDC 16571-861-25

    Olopatadine Hydrochloride Ophthalmic Solution, USP 0.2%

    ONCE DAILY RELIEF Antihistamine

    NOW AVAILABLE without a prescription
    ONCE DAILY 

    Eye Allergy Itch Relief

    Works in Minutes

    Relief from Allergens:
    •Pet Dander

    •Pollen

    •Grass

    •Ragweed

    2.5 mL                 STERILE

    olapatadine-0.2-carton.jpg

    Rising                            NDC 16571-861-25

    Olopatadine Hydrochloride Ophthalmic Solution, USP
    0.2%
    ONCE DAILY RELIEF Antihistamine
    Eye Allergy Itch Relief
    ONCE DAILY
    2.5 mL 
    STERILE

    olapatadine-0.2-container.jpg

  • INGREDIENTS AND APPEARANCE
    OLOPATADINE HYDROCHLORIDE 
    olopatadine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16571-861
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM) OLOPATADINE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE K30 (UNII: U725QWY32X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16571-861-251 in 1 CARTON05/01/2025
    12.5 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20462005/01/2025
    Labeler - Rising Pharma Holdings, Inc. (116880195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Micro Labs Limited677600482ANALYSIS(16571-861) , LABEL(16571-861) , MANUFACTURE(16571-861) , PACK(16571-861)