FLUTICARE NASAL ALERGY (fluticasone propionate- glucocorticoid spray, metered

FlutiCare by

Drug Labeling and Warnings

FlutiCare by is a Otc medication manufactured, distributed, or labeled by Innovus Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

INGREDIENTS AND APPEARANCE

FLUTICARE  NASAL ALERGY
fluticasone propionate (glucocorticoid) spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57483-005
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U)	FLUTICASONE PROPIONATE	50 ug

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57483-005-02	1 in 1 CARTON	09/22/2017
1		120 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA207957	09/22/2017

Labeler - Innovus Pharmaceuticals Inc. (962507187)

Registrant - Innovus Pharmaceuticals Inc. (962507187)