NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]

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NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS]
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NDC 63736-072-01
Set ID e16acd65-8163-4410-b645-db9bdee63b2d
Category HUMAN OTC DRUG LABEL
Packager Insight Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient (per spray)             Purpose
    oxymetazoline hydrochloride 0.05% . . . . . . . . . . . . Nasal decongestant
  • Uses

    for temporary relief of nasal congestion

    • due to a cold
    • due to hay fever or other upper respiratory allergies
    • shrinks swollen membranes so you can breathe more freely
  • Warnings

    For nasal use only. Ask a doctor before use if you have

    • heart disease
    • thyroid disease
    • high blood pressure
    • diabetes
    • trouble urinating due to an enlarged prostate gland

    When using this product

    • do not exceed recommended dosage
    • temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge may occur
    • do not use for more than 3 days. Frequent or prolonged use may cause nasal congestion to come back or get worse.
    • use only as directed

    Stop use and ask a doctor if symptoms persist

    The use of this container by more than one person may spread infection

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    do not exceed 2 doses in any 24 hour period

    adults and children 6 to under 12 years of age (with adult supervision)2 or 3 sprays in each nostril not more often than every 10 to 12 hours.
    children under 6 years of ageask a doctor
  • Inactive Ingredients

    benzalkonium chloride solution, camphor, carbomer 934P, carboxymethylcellulose sodium, edetate disodium, eucalyptol, glycine, hyaluronic acid sodium, menthol, polyethylene glycol, propylene glycol, sodium hydroxide, water.

  • PRINCIPAL DISPLAY PANEL - 1/2 FL. OZ. Bottle Carton

    NASAL
    DECONGESTANT

    Nōstrilla®
    oxymetazoline HCl USP 0.05%

    COMPLETE
    Congestion Relief

    2 in 1 Formula
    Relieves Severe
    Congestion and
    Moisturizes

    No-Drip Formula

    12 HOUR

    1/2 FL. OZ.
    (15 ML)

    PRINCIPAL DISPLAY PANEL - 1/2 FL. OZ. Bottle Carton
  • INGREDIENTS AND APPEARANCE
    NOSTRILLA 
    oxymetazoline hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-072
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Oxymetazoline Hydrochloride (UNII: K89MJ0S5VY) (Oxymetazoline - UNII:8VLN5B44ZY) Oxymetazoline0.0005 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    camphor (UNII: 5TJD82A1ET)  
    carboxymethylcellulose sodium (UNII: K679OBS311)  
    edetate disodium (UNII: 7FLD91C86K)  
    eucalyptol (UNII: RV6J6604TK)  
    glycine (UNII: TE7660XO1C)  
    menthol (UNII: L7T10EIP3A)  
    polyethylene glycol (UNII: 3WJQ0SDW1A)  
    propylene glycol (UNII: 6DC9Q167V3)  
    sodium hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-072-011 in 1 CARTON
    115 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/08/2009
    Labeler - Insight Pharmaceuticals (176792315)
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