Label: MOMETASONE FUROATE spray, metered

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated November 25, 2024

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

  • Active ingredient (in each spray)

    Mometasone furoate monohydrate (glucocorticoid) 50 mcg

  • Purpose

    Allergy symptom reliever

  • Uses

    temporarily relieves these symptoms of hay fever or other upper respiratory allergies:


          ■  nasal congestion

          ■  runny nose

          ■  sneezing

          ■  itchy nose

  • Warnings

    Only for use in the nose. Do not spray into your eyes or mouth.

  • Do not use

    ■  in children under 2 years of age

    ■  to treat asthma

    ■  if you have an injury or surgery to your nose that is not fully healed

     ■  if you have ever had an allergic reaction to this product or any of the ingredients

  • Ask a doctor before use if you

    ■  have an eye infection

    ■  have or had glaucoma or cataracts

  • Ask a doctor or pharmacist before use if you are taking

    ■  medicine for HIV infection (such as ritonavir)

    ■  a steroid medicine for asthma, allergies or skin rash

     ■  ketoconazole pills (medicine for fungal infection)

  • When using this product

    ■  the growth rate of some children may be slower

    ■  stinging may occur for a few seconds right after use

    ■  you may start to feel relief within 12 hours and full effect after several days of regular, once-a-day use

    ■  do not share this bottle with anyone else as this may spread germs

    ■  remember to tell your doctor about all the medicines you take, including this one

  • Stop use and ask a doctor if

    ■  you have, or come into contact with someone who has chickenpox, measles or tuberculosis

    ■  your symptoms do not get better within 7 days of starting use or you get new symptoms such as severe facial pain or thick nasal discharge. You may have something more than allergies, such as an infection.

    ■  you get a constant whistling sound from your nose. This may be a sign of damage inside your nose.

    ■  you get an allergic reaction to this product. Seek medical help right away.

    ■  you get new changes to your vision that develop after starting this product

    ■  you have severe or frequent nose bleeds

  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    Read insert (inside package) for how to:

             ■  prime the bottle

             ■  use the spray

             ■  clean the nozzle


    ■  shake well before each use

    ■  use this product only once a day

    ■  do  not use more than directed


    Adults & children 12 years of age and older

    ■  2 sprays in each nostril once daily while sniffing gently


    Children 2 to 11 years of age

    ■  the growth rate of some children may be slower while using this product. Children should use for the shortest amount of time necessary to achieve symptom relief. Talk to your childs doctor if your child needs to use the spray for longer than two months a year.

    ■  an adult should supervise use

    ■  1 spray in each nostril once daily while sniffing gently


    Children under 2 years of age

    ■  do not use

  • Other information

    ■ do not use if sealed carton is torn or opened

    ■ keep package and insert. They contain important information.

    ■ store between 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    benzalkonium chloride, citric acid monohydrate, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80, purified water, sodium citrate (dihydrate)

  • Questions or comments?

    Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

  • Insert

    Mometasone Furoate Nasal Spray

    50 mcg per spray

    24HR ALLERGY

    A GETTING STARTED


    Mometasone Furoate Nasal Spray works best at relieving your allergy symptoms when you get a full dose. Here’s how to get started, in five easy steps.


    1 SHAKE


    figure

    Shake spray bottle well.



    figure

    Remove cap.     
                       
    2 PRIME 

    Do this when:

    • Starting a new bottle                                           
    • Bottle has not been used in one week
    • Just cleaned nozzle

    Otherwise go to step 3 

     figure


    Aim away from face. Grasp spray bottle as shown. Pump until fine mist appears.

    Pumped ten times and still no mist?


    Spray nozzle may be clogged. See KEEP IT CLEAN, other side.

    NOTE:  There is enough medicine in the bottle to allow for priming sprays plus the number of sprays labeled on the bottle.

    3 BLOW
    figure
    Blow nose gently to clear nostrils.

    4 AIM
    figure
    Close one nostril and put tip of spray nozzle in other nostril.

    figure
    Put just the tip into your nose.

    figure
    Aim slightly away from center of nose.

    5 BREATH AND SPRAY
    figure
    While sniffing gently, press down on spray nozzle once or twice (according to dosing instructions). You’ll feel a light mist in your nose. Breathe out through your mouth.

    Repeat in other nostril.

    Wipe spray nozzle with clean tissue and replace cap.
     
    B DIRECTIONS FOR USE

    Mometasone Furoate Nasal Spray works best when you use it daily. Here’s how to get started.

    Children age 2 to 11
    figure


    An adult should supervise use
    Use one spray in each nostril once daily.

    Check with your child’s doctor
    if child needs to use Mometasone Furoate Nasal Spray for longer than two months a year.

    Users age 12 or older

    figure
    Use two sprays in each nostril every day.     

    figure
     WARNING: 
    Do not spray in your eyes. Only for use in your nose.  
                                                     
    Other important information for use
    •    Do not use more than directed.
    •    If you forget a dose, do not double the next dose.
    •    Do not spray into eyes or mouth.
    •    If you get the spray in your eyes, rinse well with water.
    •    If allergy symptoms do not improve after one week, stop using and talk to a doctor.  
    •    Do not share this bottle with anyone else as this may spread germs.


    C KEEP IT CLEAN

    A clean spray nozzle helps ensure a full dose.
    Clean it weekly, or if it’s clogged. Don’t try to unblock nozzle with pin or sharp object – that can damage it.
    figure
    Remove spray nozzle by grasping at base and pulling up.                                                                                        
    figure
    Rinse under running tap water, and dry at room temperature.

    figure
    Aim away from your face and gently, but firmly, replace spray nozzle.                                         

    figure
    If spray nozzle is clogged, soak in warm water. Then repeat steps 2 and 3.

    Questions or comments? Call toll-free 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST)

    Store between 20° to 25°C (68° to 77°F).

    Distributed by:
    AUROHEALTH LLC
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Made in India

    Code: AP/DRUGS/04/2016

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Label (120 Sprays 0.57 FL.OZ. (17 mL))

    AUROHEALTH

    NDC 58602-522-44

    Mometasone Furoate
    Nasal Spray

    50 mcg per spray

    ALLERGY SYMPTOM RELIEVER
    (GLUCOCORTICOID)
                                          
    120
    SPRAYS   0.57 FL. OZ. (17 mL)

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Label (120 Sprays 0.57 FL.OZ. (17 mL))

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Carton Label (120 Sprays 0.57 FL.OZ. (17 mL))

    AUROHEALTH

    NDC 58602-522-44
    #compare to the active ingredient in
    NASONEXTM 24HR ALLERGY

    non-drowsy / scent-free mist

    Mometasone Furoate
    Nasal Spray
    50 mcg per spray

    ALLERGY SYMPTOM RELIEVER
    (GLUCOCORTICOID)*

    ALLERGY + CONGESTION


    FULL PRESCRIPTION STRENGTH  

                                          
    24HR RELIEF of:

    nasal congestion / runny nose
    sneezing / itchy nose

    *Mometasone Furoate is a steroid
    medicine known as a glucocorticoid

    120
    SPRAYS   0.57 FL. OZ. (17 mL)
    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - Container Carton Label (120 Sprays 0.57 FL.OZ. (17 mL))


  • INGREDIENTS AND APPEARANCE
    MOMETASONE FUROATE 
    mometasone furoate spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58602-522
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MOMETASONE FUROATE MONOHYDRATE (UNII: MTW0WEG809) (MOMETASONE - UNII:8HR4QJ6DW8) MOMETASONE FUROATE50 ug
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58602-522-441 in 1 CARTON11/22/2024
    1120 in 1 BOTTLE, SPRAY; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21749811/22/2024
    Labeler - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    APL HEALTHCARE LIMITED650918514ANALYSIS(58602-522) , MANUFACTURE(58602-522)