FLUTICASONE PROPIONATE spray, metered

Fluticasone Propionate by

Drug Labeling and Warnings

Fluticasone Propionate by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Apotex 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.

Directions

• read the Quick Start Guide for how to:
  •  prime the bottle
  • use the spray
  • 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 at 4° to 30°C (39° to 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?

call toll free 1-800-706-5575, weekdays, 8:30am – 5:00pm Eastern Standard Time

Principal Display Panel - Carton 120 ms

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Rugby Laboratories NDC: 0536-1091-94

Fluticasone Propionate Nasal Spray, USP

120 sprays

Allergy Symptom Reliever Nasal Spray

24 Hour Relief of:

• Nasal Congestion
• Runny Nose
• Itchy Nose
• Sneezing

Principal Display Panel - Bottle 120 ms

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Rugby LaboratoriesNDC: 0536-1091-94

Fluticasone Propionate Nasal Spray, USP

120 sprays

Allergy Symptom Reliever Nasal Spray

Principal Display Panel - Carton 60 ms

CARTON LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray 

Rugby Laboratories NDC: 0536-1091-70

Fluticasone Propionate Nasal Spray, USP ­

60 sprays 

­Allergy Symptom Reliever Nasal Spray 

24 Hour Relief of: 

• Nasal Congestion
• Runny Nose
• Itchy Nose
• Sneezing

Principal Display Panel - Bottle 60 ms

BOTTLE LABEL - PRINCIPAL DISPLAY PANEL - 50 mcg per spray

Rugby Laboratories NDC: 0536-1091-70

Fluticasone Propionate Nasal Spray, USP ­

60 sprays

Allergy Symptom Reliever Nasal Spray

INGREDIENTS AND APPEARANCE

FLUTICASONE PROPIONATE 
fluticasone propionate spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1091
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)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
DEXTROSE (UNII: IY9XDZ35W2)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1091-94	1 in 1 CARTON	02/29/2016
1		120 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 0536-1091-70	1 in 1 CARTON	07/08/2016
2		60 in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA208150	02/29/2016

Labeler - Rugby Laboratories (079246066)

Registrant - Apotex Inc. (209429182)

Establishment
Name	Address	ID/FEI	Business Operations
Apotex Inc.		255092496	analysis(0536-1091) , manufacture(0536-1091)

Establishment
Name	Address	ID/FEI	Business Operations
Legacy Pharmaceutical Packaging		143213275	pack(0536-1091)