Label: NASAL DECONGESTANT- oxymetazoline hcl spray

  • 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 December 9, 2013

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  • Active ingredient

    Oxymetazoline HCl 0.05%

  • Purpose

    Nasal decongestant

  • Uses

    • temporarily relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
    • sinusitis
    • reduces swelling of nasal passages; shrinks swollen membranes
    • temporarily restores freer breathing through the nose
  • Warnings

    Do not use this product for more than 3 days

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate

    When using this product

    • do not exceed recommended dosage
    • use only as directed. frequent of prolonged use may cause nasal congestion to recur or worsen
    • temporary discomfort such as burning, stinging, sneezing or an increase in nasal discharge may occur
    • 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 right away.

  • Directions

    • To spray, squeeze bottle qiuckly and firmly
    • Do not tilt head backward while spraying
    • Wipe nozzle clean after use
    • 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
    • chlidren under 6 years of age: ask a doctor

  • Other information

    • store at room temperature 15 - 30°C (59-86°F)
    • retain carton for future reference on full labeling
    • SAFETY SEAL: Do not use if seal on bottle is broken or missing
  • Inactive ingredients

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

  • Carton image

    image of carton

  • INGREDIENTS AND APPEARANCE
    NASAL DECONGESTANT 
    oxymetazoline hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0193
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-0193-51 in 1 BOX
    130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/09/2013
    Labeler - Promex, LLC (789974388)
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