Label: CLEANOTE SALINE NASAL SPRAYS- sodium chloride 0.9% aerosol, spray

  • NDC Code(s): 83740-101-01, 83740-101-02, 83740-101-03
  • Packager: Cloudgoose Biology Science & Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

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  • SPL UNCLASSIFIED SECTION

    Cleanote saline nasal spray

  • ACTIVE INGREDIENT

    Sodium Chloride 0.9%

  • PURPOSE

    Provide instant relief and a refreshing sensation to congested or dryirritated nasal passage due to cold, allergies, smoking, air pollution, dryair, and air travel. and use of decongestants/steroidal sprays.

  • INDICATIONS & USAGE

    Provide instant relief and a refreshing sensation to congested or dryirritated nasal passage due to cold, allergies, smoking, air pollution, dryair, and air travel. and use of decongestants/steroidal sprays.

  • WARNINGS

    lf pregnant or breast feeding, ask a health professional before use.Keep out of reach of children.

  • DO NOT USE

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

  • WHEN USING

    adults and children 3 years oldand over.
    press pump 6~8 times in eachnostril as often as needed or asdirected by physician.
    children under 3 years old
    press pump 1~2 times in eachnostril as often as needed or asdirected by physician.

  • STOP USE

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

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    adults and children 3 years oldand over.
    press pump 6~8 times in eachnostril as often as needed or asdirected by physician.
    children under 3 years old
    press pump 1~2 times in eachnostril as often as needed or asdirected by physician.

  • STORAGE AND HANDLING

    store at room temperature

  • INACTIVE INGREDIENT

    Peppermint oil

    Eucalyptus oil
    Benzalkonium chloride
    Polysorbate 80
    Purified water

  • PRINCIPAL DISPLAY PANEL

    labellabel2label3label4

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  • INGREDIENTS AND APPEARANCE
    CLEANOTE SALINE NASAL SPRAYS 
    sodium chloride 0.9% aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83740-101
    Route of AdministrationINTRASINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE9 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83740-101-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product10/23/2023
    2NDC:83740-101-02100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/23/2023
    3NDC:83740-101-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product10/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01210/23/2023
    Labeler - Cloudgoose Biology Science & Technology Co., Ltd. (420735544)
    Registrant - Cloudgoose Biology Science & Technology Co., Ltd. (420735544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cloudgoose Biology Science & Technology Co., Ltd.420735544manufacture(83740-101)
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