Label: NASAL- oxymetazoline hydrochloride 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 August 23, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Oxymetazoline Hydrochloride 0.05%

  • Purpose

    Nasal Decongestant

  • Uses

    • temporary relieves nasal congestion due to:
    • common cold
    • hay fever
    • upper respiratory allergies
    • sinusitis
    • shrinks swollen nasal membranes so you can breathe more freely
  • Warnings

    Ask a doctor before use if you have

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

    When using this product: do not use more than directed

    • do not use for more than 3 days. Use only as directed. Frequent or 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 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

    • 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 within any 24-hour period
    • children under 6 years of age: ask a doctor

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

  • Other information

  • STORAGE AND HANDLING

    • store between 20° to 25° C (68° to 77° F)
    • retain carton for future reference on full labeling.
  • Inactive ingredients

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

  • Questions or Comments?

    1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

  • PRINCIPAL DISPLAY PANEL - 15 mL Carton

    WE CARE

    12 Hour NASAL SPRAY
    DECONGESTANT

    oxymetazoline hydrochloride 0.05%

    Compare to active ingredient of Afrin

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  • INGREDIENTS AND APPEARANCE
    NASAL 
    oxymetazoline hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-038
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    POVIDONE (UNII: FZ989GH94E)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70005-038-011 in 1 CARTON08/23/2016
    115 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 FINALpart34108/23/2016
    Labeler - We Care Distributor Inc. (079832998)
    Establishment
    NameAddressID/FEIBusiness Operations
    PURINE PHARMA LLC019950491manufacture(70005-038)
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