Label: OXYMETAZOLINE HYDROCHLORIDE spray, metered

  • Category: HUMAN OTC DRUG LABEL

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 February 21, 2011

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  • Active ingredient

    Oxymetazoline HCl 0.05%

  • Purpose

    Nasal decongestant

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    temporary relief of nasal congestion

    ° due to the common cold

    ° due to hay fever or other upper respiratory allergies

    ° associated with sinusitis

    reduces swelling of nasal passages

    temporarily restores freer breathing through the nose

  • Warnings

    Do not exceed recommended dosage

    This product may cause temporary discomfort such as burning, stinging, sneezing, or an increase in nasal discharge. The use of this container by more than one person may spread infection.

    Do not use 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 gland

    When using this product, frequent or prolonged use may cause nasal congestion to recur or worsen.

    Stop use and ask a doctor if symptoms persist.

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

  • Directions

    ° Adults and children 6 to under 12 years of age (with supervision): 2 to 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

    ° To spray: squeeze the bottle quickly and firmly. Do not tilt head backward while spraying. Wipe nozzle clean after use.

  • Inactive ingredients

    benzalkonium chloride, dibasic sodium phosphate (anhydrous), edetate disodium (dihydrate), monobasic sodium phosphate (monohydrate), polyethylene glycol 1450, povidone, propylene glycol, purified water.

    Questions? Cal 1-866-923-4914

  • Package/Label Principal Display Panel

    Nasal Spray 0.05%

  • INGREDIENTS AND APPEARANCE
    OXYMETAZOLINE HYDROCHLORIDE 
    oxymetazoline hydrochloride spray, metered
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-875(NDC:51672-2030)
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-875-1515 mL in 1 BOTTLE, SPRAY
    2NDC:21695-875-3030 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34112/11/2008
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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