Label: WINCO FOODS SALINE NASAL- sodium chloride 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 November 26, 2014

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  • ACTIVE INGREDIENT


    Active Ingredient                                                                                                            Purpose

    Sodium chloride 0.65%-----------------------------------------------------------------------  Moisturizer

  • PURPOSE

    Uses

    • For dry nasal membranes
  • WARNINGS

    Warnings

    keep out of reach of children

    The use of this dispenser by more than one person may spread infections

  • KEEP OUT OF REACH OF CHILDREN

    Warnings

    keep out of reach of children

    The use of this dispenser by more than one person may spread infections

  • INDICATIONS & USAGE

    Direction

    • Squeeze wtice in each nostril as needed
    • Uprifht delivers a spray, horizontally a stream, upside down a drop
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, dibasic sodium phosphate, monobasic sodium phosphate, 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 SALINE NASAL 
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67091-194
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE.65 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67091-194-4645 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/26/2014
    Labeler - WinCo Foods, LLC (056098817)
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