Label: NOSTRILLA- oxymetazoline hydrochloride spray, metered

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 19, 2009

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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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