CLARISPRAY NASAL ALLERGY- fluticasone propionate (glucocorticoid) spray, metered 
Bayer HealthCare LLC.

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ClariSpray Nasal Allergy 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 infections)

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.

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 label and enclosed materials. They contain important additional information.

Inactive ingredients

0.02% w/w benzalkonium chloride, dextrose, microcrystalline cellulose and carboxymethylcellulose sodium, 0.25% w/w phenylethyl alcohol, polysorbate 80, purified water

Questions or comments?

1-866-511-9330 (Mon-Fri 9-5 EST)

Directions

read the Quick Start Guide for how to:

  • prime the bottle
  • use the spray
  • clean the 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

CONTAINS THE DRUG

FLUTICASONE PROPIONATE

From the Makers of

CLARITIN

ClariSpray

Nasal Allergy Spray

Fluticasone Propionate Nasal Spray, USP

50 mcg Per Spray

(glucocorticoid)

Allergy Symptom Reliever Nasal Spray

Full Prescription

Strength

Non-Drowsy

24

HOUR

Relief of:

  • Itchy, Watery Eyes
  • Nasal Congestion
  • Runny Nose
  • Itchy Nose
  • Sneezing

BAYER

120 METERED SPRAYS

.54 fl oz (15.8 mL)

clarispray

CLARISPRAY  NASAL ALLERGY
fluticasone propionate (glucocorticoid) spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-0072
Route of AdministrationNASAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUTICASONE PROPIONATE (UNII: O2GMZ0LF5W) (FLUTICASONE - UNII:CUT2W21N7U) FLUTICASONE PROPIONATE50 ug
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
DEXTROSE (UNII: IY9XDZ35W2)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-0072-151 in 1 CARTON04/20/201610/31/2019
1120 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2NDC:0280-0072-101 in 1 CARTON04/20/201610/31/2019
260 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20815004/20/201610/31/2019
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 9/2018
 
Bayer HealthCare LLC.