WINCO FOODS ORIGINAL NASAL (OXYMETAZOLINE HCL) SPRAY [WINCO FOODS, LLC]

WINCO FOODS ORIGINAL NASAL (OXYMETAZOLINE HCL) SPRAY [WINCO FOODS, LLC]
PDF | XML

NDC 67091-193-30
Set ID b387ec58-b3d1-4ac9-87c0-a0147383e6b7
Category HUMAN OTC DRUG LABEL
Packager WinCo Foods, LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT


    Active Ingredient                                                                                                            Purpose

    Oxymetazoline HCL 0.05%-----------------------------------------------------------------------  Nasal decongestant

  • PURPOSE

    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

    Warnings

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • trouble urinating due to an enlarged prostate gland
  • WHEN USING

    When using this product

    • do not use more than directed
    • do not use more than 3 days. 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

    Stop use and ask a doctor if symptoms persist

  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Direction

    • adults and children 6 to 12 years of age (with adult supervision): 2 or 3 sprays in each nostril not more 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
    • Shake well before use.  To spray, hold bottle with thumb at base and nozzle between first and second fingers.  Without tilting head, insert nozzle into nostril.  Fully depress rim with a firm, even stroke and sniff deeply.  Wipe nozzle clean after use.
  • STORAGE AND HANDLING

    Other information

    • Store between 20° and 25°C (68° and 77°F)
    • Retain carton for future reference on fully labeling
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, benzyl alcohol, dibasic sodium phosphate hydrate, disodium EDTA, distilled water, monobasic sodium phosphate dihydrate, PEG 1450, PVP K30

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WINCO FODDS, LLC,

    BOISE, ID 83704

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WINCO FOODS ORIGINAL NASAL 
    oxymetazoline hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-193
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-193-301 in 1 CARTON
    130 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34111/26/2014
    Labeler - WinCo Foods, LLC (056098817)

Related Drugs