SALINE NASAL 2OZ (SODIUM CHLORIDE 0.65%) SPRAY [LEE PHARMACEUTICALS]

SALINE NASAL 2OZ (SODIUM CHLORIDE 0.65%) SPRAY [LEE PHARMACEUTICALS]
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NDC 23558-6881-1
Set ID a0f510bd-5202-40f2-a678-84ee79544c9c
Category HUMAN OTC DRUG LABEL
Packager Lee Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART349
  • Active ingredient

    Sodium Chloride, 0.65%

  • Purpose

    Moisturizer

  • Uses

    For dry nasal membranes

  • Warnings

    Do not use if seal is broken or missing.

    Keep out of reach of children. The use of this dispenser by more than one person may spread infection.

  • Directions

    • Squeeze twice in each nostril as needed
    • Upright delivers a spray, horizontally a stream, upside down a drop
  • Inactive ingredients

    Benzalkonium chloride, Disodium phosphate, Phenylcarbinol, Monosodium phosphate, Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SALINE NASAL  2OZ
    sodium chloride 0.65% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23558-6881
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23558-6881-159 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/01/2013
    Labeler - Lee Pharmaceuticals (056425432)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432manufacture(23558-6881)

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