12 HOUR NASAL (OXYMETAZOLINE HCL) SPRAY [SELECT BRAND DISTRIBUTORS]

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12 HOUR NASAL (OXYMETAZOLINE HCL) SPRAY [SELECT BRAND DISTRIBUTORS]
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NDC 15127-304-10
Set ID 62c62ba3-1f24-48f6-a5cd-106614646c2a
Category HUMAN OTC DRUG LABEL
Packager Select Brand Distributors
Generic Name
Product Class
Product Number
Application Number PART341
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  • ACTIVE INGREDIENT

    Active ingredient
    Oxymetazoline HCl 0.05%

  • PURPOSE

    Purpose
    Oxymetazoline HCl................ Nasal decongestant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves nasal congestion due to:    • common cold    • hay fever    • upper respiratory allergies
    • temporarily relieves sinus congestion and pressure
    • shrinks swollen nasal membranes so you can breathe more freely
  • WARNINGS

    ​Warnings

    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 recur or worsen.
    • use only as directed
    • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    •  to spray, squeeze bottle quickly 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
    • children under 6 years of age: ask a doctor
  • OTHER SAFETY INFORMATION

    Other information

    •  RETAIN CARTON FOR FUTURE REFERENCE ON FULL LABELING
    •  store between 2°-30°C (36°-86°F)
  • INACTIVE INGREDIENT

    Inactive ingredients
    benzalkonium chloride 0.01%, edetate disodium, polyethylene glycol 1450, povidone, propylene glycol, sodium phosphate dibasic, sodium phosphate monobasic, water

  • PRINCIPAL DISPLAY PANEL

    carton

    SelBr12hrNascart.jpg

  • INGREDIENTS AND APPEARANCE
    12 HOUR NASAL 
    oxymetazoline hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-304
    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 GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    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:15127-304-101 in 1 CARTON03/01/200004/30/2020
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34103/01/200004/30/2020
    Labeler - Select Brand Distributors (012578514)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(15127-304) , pack(15127-304) , label(15127-304)
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