Label: FLUTICARE NASAL ALERGY (fluticasone propionate- glucocorticoid spray, metered
- NDC Code(s): 57483-005-03
- Packager: Innovus Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 28, 2022
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- Official Label (Printer Friendly)
- Active ingredient (in each spray)
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 ingredientsAsk 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 slowe
- 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
- 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
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.
- 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
- Questions or comments?
- Package/Label Principal Display Panel
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:57483-005-03 1 in 1 CARTON 09/22/2017 1 120 in 1 BOTTLE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 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)