FLONASE- fluticasone propionate spray, metered 
GlaxoSmithKline Inc

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Drug Facts

Principal Display Panel

NDC 0135-0576-03

FLONASE®

ALLERGY RELIEF

FULL PRESCRIPTION STRENGTH * NON-DROWSY

Fluticasone Propionate (Glucocorticoid) 50 mcg Per Spray

Allergy Symptom Reliever Nasal Spray

24 Hour Relief of:

Itchy, Watery Eyes
Nasal Congestion
Runny Nose
Itchy Nose
Sneezing

24 HOUR RELIEF

120 METERED SPRAYS

0.54 fl oz (15.8 mL)

FLONASE, the FLONASE logo, the bottle and cap design, and other design elements are trademarks of the GSK group of companies.

IMPORTANT – Peel here for complete Drug Facts label. Children 4-11: do not use for more than 2 months a year.

Be sure to read the Quick Start Guide and Question & Answer Book inside package

TAMPER-EVIDENT features for your protection.

The product is packaged in a sealed plastic container. Under the cap and nozzle, each bottle has an aluminum seal around bottle neck.

Do not use if any of these features are torn or damaged.

Distributed by:

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in Canada

What problems can FLONASE® Allergy Relief help with?

FLONASE® Allergy Relief helps relieve a broad range of uncomfortable symptoms like congestion and itchy eyes.

Nasal symptoms

Eye symptoms

These symptoms can be triggered by allergens like pollen, mold, dust or pet dander.

Outdoor allergens

Animal allergens

Indoor allergens

 
Blister card: 104447XB ©2015 GSK
 
Peel Back Label: 104448XB ©2015 GSK
Flonase 120 count backcard
FLONASE 
fluticasone propionate spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53873-038
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53873-038-001 in 1 PACKAGE10/09/2014
160 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
2NDC:53873-038-011 in 1 PACKAGE10/09/2014
2120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
3NDC:53873-038-021 in 1 PACKAGE02/29/2016
330 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
4NDC:53873-038-031 in 1 PACKAGE10/17/2016
4144 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Approved Drug Product Manufactured Under ContractNDA20543410/09/2014
Labeler - GlaxoSmithKline Inc (205556368)

Revised: 12/2017
 
GlaxoSmithKline Inc