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

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NOSTRILLA (OXYMETAZOLINE HYDROCHLORIDE) SPRAY, METERED [INSIGHT PHARMACEUTICALS LLC]
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NDC 63736-730-01, 63736-730-02
Set ID 86217847-8e2b-48cc-b289-4987fd3aa7c3
Category HUMAN OTC DRUG LABEL
Packager Insight Pharmaceuticals LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (per spray)

    oxymetazoline hydrochloride 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    • temporarily relieves nasal congestion due to:
      ▪ a cold
      ▪ hay fever
      ▪ upper respiratory allergies
      ▪ helps clear nasal passages; shrinks swollen membranes
      ▪ temporarily restores freer breathing through the nose
  • Warnings

    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. Use only as directed. Frequent or prolonged use may cause nasal congestion to recur or worsen.
    • use of this container by more than one person may spread infection

    Stop use and ask a doctor if

    symptoms persist

    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 (1-800-222-1222) right away.

  • Directions

    • 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. Do not exceed 2 doses in any 24 hour period
    • children under 6 years of age: ask a doctor

    Squeeze and unscrew to remove the protective cap. Align rail grooves and prime pump by depressing it firmly several times (see illustration on side). Hold bottle with thumb at base and nozzle between first and second fingers. With head upright, insert nozzle into nostril. Depress pump two or three times, all the way down, and sniff deeply.

  • Other Information

    • store between 20° – 25°C (68° – 77°F). Avoid excessive heat or freezing.
    • keep carton for full drug facts
  • Inactive ingredients

    benzalkonium chloride, edetate disodium, glycerin, polyethylene glycol, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

  • Questions or comments?

    1-800-344-7239

  • PRINCIPAL DISPLAY PANEL

    Nōstrilla® 
    Oxymetazoline HCl Nasal Solution
    NASAL DECONGESTANT
    1/2 FL. OZ (15 mL)

    Nōstrilla® Oxymetazoline HCl Nasal Solution NASAL DECONGESTANT 1/2 FL. OZ (15 mL)

  • INGREDIENTS AND APPEARANCE
    NOSTRILLA 
    oxymetazoline hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-730
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-730-011 in 1 CARTON06/08/2009
    115 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:63736-730-021 in 1 CARTON06/08/2009
    222.5 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34106/08/2009
    Labeler - Insight Pharmaceuticals LLC (055665422)
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