WINCO FOODS EXTRA MOISTURIZING NASAL RELIEF (OXYMETAZOLINE HCL) SPRAY [WINCO FOODS, LLC]

WINCO FOODS EXTRA MOISTURIZING NASAL RELIEF (OXYMETAZOLINE HCL) SPRAY [WINCO FOODS, LLC]
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NDC 67091-191-30
Set ID d3cc5e60-5350-40a9-9453-404fbfc160f4
Category HUMAN OTC DRUG LABEL
Packager WinCo Foods, LLC
Generic Name
Product Class
Product Number
Application Number PART341
  • ACTIVE INGREDIENT

    Active Ingredient                                                                                                          Purpose

    Oxymetazoline HCI 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 open, rotate cap to align the marks. Squeeze cap on both sides in a counterclockwise turn and pull off to remove. To spray, remove clamp and hold bottle with thumb at base and nozzle between first and second fingers. Without tilting the head, insert nozzle into nostril. Fully depress rim with a firm, even stroke and sniff deeply. Wipe nozzle clean after each use and snap cap back onto the bottle.
  • 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, glycerin, monobasic sodium phosphate dihydrate, polyethylene glycol 1450, polyvinylpyrrolidone K30, purified water

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    WINCO FODDS, LLC,

    BOISE, ID 83704

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WINCO FOODS EXTRA MOISTURIZING NASAL RELIEF 
    oxymetazoline hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-191
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYMETAZOLINE HYDROCHLORIDE (UNII: K89MJ0S5VY) (OXYMETAZOLINE - UNII:8VLN5B44ZY) OXYMETAZOLINE HYDROCHLORIDE.005 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    POVIDONE K30 (UNII: U725QWY32X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-191-301 in 1 CARTON11/02/2016
    130 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 finalpart34111/26/2014
    Labeler - WinCo Foods, LLC (056098817)

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