FLUTICARE NASAL ALERGY- fluticasone propionate (glucocorticoid) spray, metered 
Innovus Pharmaceuticals Inc.

----------

FlutiCare Nasal Allergy Spray

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:

Warnings

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

Do not use

Ask a doctor or pharmacist before use if you are taking

When using this product

Stop use and ask a doctor if

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

-prime the bottle
-use the spray
-clean the spray nozzle

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER

CHILDREN 4 TO 11 YEARS OF AGE

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.

CHILDREN UNDER 4 YEARS OF AGE

Other information

TAMPER EVIDENT: Do not use if plastic sleeve is torn or broken. Under the cap and nozzle, each bottle has an aluminum seal around the bottle neck. Do not use if any of these featurees are torn or damaged.

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?

1-800-262-9010

Package/Label Principal Display Panel

Fluticare Carton

FLUTICARE  NASAL ALERGY
fluticasone propionate (glucocorticoid) spray, metered
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57483-005
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:57483-005-031 in 1 CARTON09/22/2017
1120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
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: 12/2023
Document Id: 38e97042-b4b6-4ee3-8733-84cce07fbb05
Set id: c72952e6-bfe5-485b-8c62-787ff4179b62
Version: 6
Effective Time: 20231208
 
Innovus Pharmaceuticals Inc.