GOOD SENSE NASAL ALLERGY (TRIAMCINOLONE ACETONIDE) SPRAY, METERED [L. PERRIGO COMPANY]

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GOOD SENSE NASAL ALLERGY (TRIAMCINOLONE ACETONIDE) SPRAY, METERED [L. PERRIGO COMPANY]
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NDC 0113-0443-01
Set ID 082c79e9-d6b2-40b8-baf9-2a91b9ecaea4
Category HUMAN OTC DRUG LABEL
Packager L. Perrigo Company
Generic Name
Product Class
Product Number
Application Number ANDA078104
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  • Active ingredient (in each spray)

    Triamcinolone acetonide 55 mcg (glucocorticoid)

  • 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

    Do not use

    •
    in children under 2 years of age
    •
    if you have ever had an allergic reaction to any of the ingredients

    Ask a doctor before use if you

    •
    have had recent nose ulcers or nose surgery
    •
    have had a nose injury that has not healed
    •
    are using a steroid medicine for asthma, allergies or skin rash
    •
    have an eye infection
    •
    have or had glaucoma or cataracts

    When using this product

    •
    the growth rate of some children may be slower
    •
    some symptoms may get better on the first day of treatment. It may take up to one week of daily use to feel the most symptom relief.
    •
    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
    •
    you have or develop symptoms of an infection such as a persistent fever
    •
    you have any change in vision
    •
    you have severe or frequent nosebleeds

    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) on how to:

    •
    get a new bottle ready (primed) before first use
    •
    prime bottle again if not used for more than 2 weeks
    •
    use the spray
    •
    clean the spray nozzle

    ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

    adults and children

    12 years of age

    and older

    •
    once daily, spray 2 times into each nostril while sniffing gently
    •
    once your allergy symptoms improve, reduce to 1 spray in each nostril per day

    CHILDREN 2 TO UNDER 12 YEARS OF AGE

    •
    the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.

    children 6 to under

    12 years of age

    •
    an adult should supervise use
    •
    once daily, spray 1 time into each nostril while sniffing gently
    •
    if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day.

    children 2 to under 6 years of age

    •
    an adult should supervise use
    •
    once daily, spray 1 time into each nostril while sniffing gently

    children under 2 years of age

    •
    do not 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 allergy symptoms do not improve after one week, stop using and talk to a doctor
    •
    do not use for the common cold
    •
    shake well before each use
  • Other information

    •
    do not use if printed bottle wrap is torn or opened
    •
    keep package and insert. They contain important information.
    •
    store between 20°-25°C (68°-77°F)
  • Inactive ingredients

    benzalkonium chloride, carboxymethylcellulose sodium, dextrose anhydrous, edetate disodium dihydrate, hydrochloric acid or sodium hydroxide (for pH adjustment), microcrystalline cellulose, polysorbate 80, purified water

  • Questions or comments?

    1-800-719-9260

  • Consumer Information

    Triamcinolone Acetonide Nasal Spray 55 mcg per spray

    IMPORTANT INFORMATION

    •
    Read both sides of this insert for complete instructions on how to get a bottle ready (primed), how to use the spray bottle and how to clean the spray nozzle.
    •
    Keep this insert as it contains important information.

    STEPS TO GET A NEW BOTTLE READY FOR USE (PRIMED)

    1. Before first use, a new bottle must be primed.

    a.
    Remove cap and safety clip (Figure A).
    b.
    Shake bottle.
    c.
    Press and release spray nozzle until a fine mist is produced (as shown in Figure B). This may take several times. Take care not to spray in face.
    Figure A

    PRIME BOTTLE AGAIN IF NOT USED FOR MORE THAN 2 WEEKS

    •
    Repeat steps for priming a bottle (see above).

    USE INSTRUCTIONS

    1.
    Blow nose gently to clear nostrils.
    2.
    Remove cap and safety clip, then shake bottle.
    3.
    Hold bottle with thumb under bottle and spray nozzle between fingers (as shown in Figure B).
    4.
    Press against the outside of your nose with your finger to close off one nostril (as shown in Figure C).
    5.
    Place the tip of the spray nozzle into the other nostril. The spray nozzle should not reach far into the nose. Aim nozzle toward back of nose (as shown in Figure C).
    Figure B

    DO NOT spray toward nasal septum (the wall between the 2 nostrils) (as shown in Figure D).

    Figures C & D
     
    6. While sniffing gently, spray into nostril.

    IMPORTANT: For complete dosing instructions, See “Directions for use” on next side.

     
    7. Repeat steps “4” through “6” for the other nostril.
     
    8. After using the nasal spray, wipe nozzle with a tissue, replace safety clip, and replace cap by pressing it down over the spray nozzle.

    NOTE: Avoid blowing nose for 15 minutes after use.

    If nozzle does not spray properly, see cleaning instructions on next side.

    (continued on side 2)

    SIDE 1

    DIRECTIONS FOR USE

    •
    BEFORE first use, you must get a new bottle ready (primed).
    •
    If bottle is not used for more than 2 weeks, prime bottle again.

    Dosing

    ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

    adults and children 12 years of age and older

    •
    once daily, spray 2 times into each nostril while sniffing gently
    •
    once your allergy symptoms improve, reduce to 1 spray in each nostril per day

    CHILDREN 2 TO UNDER 12 YEARS OF AGE

    •
    the growth rate of some children may be slower while using this product. Talk to your child’s doctor if your child needs to use the spray for longer than two months a year.

    children 6 to under 12 years of age

    •
    an adult should supervise use
    •
    once daily, spray 1 time into each nostril while sniffing gently
    •
    if allergy symptoms do not improve, increase to 2 sprays in each nostril per day. Once allergy symptoms improve, reduce to 1 spray in each nostril per day.

    children 2 to under 6 years of age

    •
    an adult should supervise use
    •
    once daily, spray 1 time into each nostril while sniffing gently

    children under 2 years of age

    •
    do not use

    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.

    IF PUMP DOES NOT SPRAY PROPERLY, THE NOZZLE MAY BE BLOCKED

    1.
    Never try to unblock nozzle with a pin or any other object (as shown in Figure E).
    2.
    Clean the nozzle as shown below.
    Figure E

    CLEANING INSTRUCTIONS

    1.
    Gently pull spray nozzle away from bottle (as shown in Figure F).
    2.
    Rinse SPRAY NOZZLE ONLY under warm water (as shown in Figure G).
    3.
    Shake or tap to remove excess water.
    4.
    Re-attach spray nozzle to bottle.
    5.
    Press and release spray nozzle until a fine spray is produced, taking care not to spray in face.
    Figure F
    Figure G

    Triamcinolone Acetonide Nasal Spray pump is now ready to use.

    Where can I get more information? 1-800-719-9260

    Store between 20°-25°C (68°-77°F)

    Made in Israel

    Distributed By

    Perrigo®

    Allegan, MI 49010

    SIDE 2

    : 44300 00 J4

  • Package/Label Principal Display Panel

    Multi-Symptom

    Nasal Allergy Spray

    Triamcinolone Acetonide Nasal Spray 55 mcg per spray

    Allergy Symptom Reliever (Glucocorticoid)*

    Original Prescription Strength

    24 HR Relief of:

    Nasal Congestion

    Runny Nose - Sneezing

    Itchy Nose

    24 HOUR

    Non-Drowsy/Scent-Free/Alcohol-Free

    120 Sprays

    Compare to active ingredient of Nasacort® Allergy 24HR

    0.57 FL OZ (16.9 mL)

    *Triamcinolone acetonide is a steroid medicine known as a glucocorticoid.

    443C2-allergy-nasal
  • INGREDIENTS AND APPEARANCE
    GOOD SENSE NASAL ALLERGY 
    triamcinolone acetonide spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0113-0443
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) TRIAMCINOLONE ACETONIDE55 ug
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITE (off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0113-0443-011 in 1 CARTON02/09/2017
    1120 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07810402/09/2017
    Labeler - L. Perrigo Company (006013346)
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