12 HOUR NASAL (OXYMETAZOLINE HCL) SPRAY [HEALTHLIFE OF USA]

12 HOUR NASAL (OXYMETAZOLINE HCL) SPRAY [HEALTHLIFE OF USA]
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NDC 69517-613-17
Set ID 1c538da1-a005-4d05-9e59-d21c0882a676
Category HUMAN OTC DRUG LABEL
Packager Healthlife of USA
Generic Name
Product Class
Product Number
Application Number PART341
  • Drug Facts

  • Active Ingredient

    Oxymetazoline HCL 0.05%

  • Purpose 

    Nasal Decongestant 

  • Uses

    Temporarily 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 an 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 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

    • 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 six 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

    • store between 20°C to 40°C (68°F to 104°F)
    • retain carton for future reference on full labeling.
  • Inactive Ingredients

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

  • Questions or Comments?

    1-844-832-1138 Monday through Friday 9am-5pm

  • PRINCPAL DISPLAY PANEL - 15mL Bottle Carton

    12 Hour Nasal Spray 

    Nasal Decongestant 

    Original 

    0.5 Fl.OZ (15 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    12 HOUR NASAL 
    oxymetazoline hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69517-613
    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)  
    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:69517-613-171 in 1 CARTON01/02/2018
    115 mL in 1 BOTTLE, PUMP; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/02/2018
    Labeler - Healthlife of USA (079656178)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kingston Pharmaceuticals080386521manufacture(69517-613)

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