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fluticasone propionate by Innovus Pharmaceuticals Inc.

Dosage form: spray, metered
Ingredients: FLUTICASONE PROPIONATE 50ug
Labeler: Innovus Pharmaceuticals Inc.
NDC Code: 57483-005

Fluticasone Propionate Nasal Spray Drug Facts

Active ingredient (in each spray)

Fluticasone propionate (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

itchy, watery eyes

Warnings

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

Do not use

in children under 4 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 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 or sneezing may occur for a few seconds right after 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, chicken pox, 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 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 the Instructions for Use for how to:
o
prime the bottle
o
use the spray
o
clean the spray nozzle
shake gently before each use
use this product only once a day
do not use more than directed

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

Week 1 – use 2 sprays in each nostril once daily
Week 2 through 6 months – use 1 or 2 sprays in each nostril once daily, as needed to treat your symptoms
After 6 months of daily use – ask your doctor if you can keep using

CHILDREN 4 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 child’s doctor if your child needs to use the spray for longer than two months a year.
an adult should supervise use
use 1 spray in each nostril once daily

CHILDREN UNDER 4 YEARS OF AGE

do not use

Other information
you may start to feel relief the first day and full effect after several days of regular, once-a-day use
store between 4° and 30°C (39° and 86°F)

keep this package and enclosed materials. They contain important additional information.

Inactive Ingredients

benzalkonium chloride, dextrose, microcrystalline cellulose, phenylethyl alcohol, polysorbate 80, purified water, sodium carboxymethylcellulose

Questions or comments?

1-800-962-8364

Distributed By:
Innovus Pharmaceuticals, Inc.
San Diego, CA 92122

Revised September 2017
062017/00

Instructions For Use

FlutiCare Allergy Symptom Reliever Nasal Spray

Fluticasone propionate (glucocorticoid) 50 mcg per spray

(FLOO-tih-kah-sone)

FlutiCare nasal spray is for use in your nose only.

Read this information before you start using your FlutiCare nasal spray.

Your FlutiCare nasal spray must be primed before you use it for the first time and when you have not used it for a week or more.

How to prime your FlutiCare nasal spray:

Shake the bottle gently and then remove the dust cap (Figure 1).

Figure 1

Hold the bottle as shown (Figure 2) with the nasal applicator pointing away from you and with your forefinger and middle finger on either side of the nasal applicator and your thumb underneath the bottle.
Press down and release 6 times until a fine spray appears (Figure 2). The pump is now ready for use.

Figure 2

Using your FlutiCare nasal spray:

Step 1: Blow your nose to clear your nostrils.

Step 2: Close 1 nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applicator into the other nostril (Figure 3).

Figure 3

Step 3: Start to breathe in through your nose, and while breathing in press firmly and quickly down 1 time on the applicator to release the spray. To get a full dose, use your forefinger and middle finger to spray while supporting the base of the bottle with your thumb. Avoid spraying in eyes. Breathe in gently through the nostril (Figure 4).

Figure 4

Step 4: Breathe out through your mouth.

Step 5: If a second spray is required in that nostril, repeat steps 2 through 4.

Step 6: Repeat steps 2 through 5 in the other nostril.

Step 7: Wipe the nasal applicator with a clean tissue and replace the dust cap (Figure 5).

Figure 5

Do not use this bottle for more than the labeled number of sprays even though the bottle is not completely empty.

Cleaning your FlutiCare nasal spray:

Your nasal spray should be cleaned at least 1 time each week.

1.
Remove the dust cap and then gently pull upwards to free the nasal applicator.
2.
Wash the applicator and dust cap under warm tap water. Allow to dry at room temperature.
3.
Place the applicator and dust cap back on the bottle.
4.
If the nasal applicator becomes blocked, it can be removed and left to soak in warm water. Rinse the nasal applicator with cold tap water. Dry the nasal applicator and place it back on the bottle. Do not try to unblock the nasal applicator by inserting a pin or other sharp object.

Storing your FlutiCare nasal spray:

Store between 39° and 86°F (4° and 30°C).
Do not use your FlutiCare nasal spray after the date shown as “EXP” on the label or box.

Distributed by:
Innovus Pharmaceuticals, Inc.
San Diego, CA 92122

Revised September 2017
062017/00

Package/Label Principal Display Panel

NDC: 57483-005-02

FLUTICASONE PROPIONATE 
fluticasone propionate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-005
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE50 ug
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
DEXTROSE, UNSPECIFIED FORM 
MICROCRYSTALLINE CELLULOSE 
PHENYLETHYL ALCOHOL 
POLYSORBATE 80 
WATER 
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 
Packaging
#Item CodePackage Description
1NDC:57483-005-021 BOTTLE in 1 CARTON
1120 SPRAY, METERED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20795709/22/2017
Labeler - Innovus Pharmaceuticals Inc. (962507187)
Registrant - Innovus Pharmaceuticals Inc. (962507187)

Revised: 09/2017
 
Innovus Pharmaceuticals Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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