Label: NASAL WASH SALINE- sodium chloride liquid

  • NDC Code(s): 83660-001-11, 83660-001-12, 83660-001-21, 83660-001-22
  • Packager: Shenzhen Jun&Liang Media Tech Limited
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 31, 2023

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  • ACTIVE INGREDIENT

    Active ingredient(in each dosage unit): Sodium chloride

  • PURPOSE

    Purpose: Clean the nasal cavity

  • INDICATIONS & USAGE

    Uses: Work with Gailyus’s nasal washer

  • WARNINGS

    Warnings: Do not use with illegal drugs, alcohol, or non-prescribed medications

  • ASK DOCTOR

    Ask a doctor before use:
    If you have an ear infection or if your ears are blocked.
    If your nasal passages are completely blocked.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use: if you recently had ear or nose surgery.

  • WHEN USING

    When using this product:
    Do not use regular tap water. It recommends working with distilled, sterile or previously boiled water.

  • STOP USE

    Stop use and ask a doctor if:
    Your symptoms persist or worsen; or your nasal illness doesn’t improve after rinsing.

  • 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. In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Water

  • DESCRIPTION

    Directions:
    Place a new, unused saline capsule in the Gailyus nasal washer’s crushing chamber, and keep the foil-side down.
    The optimal water temperature is around 35℃-40℃ (95℉-104℉) for rinsing nasal.

  • QUESTIONS

    Questions?You can email us at Gailyus@outlook.com for more help!

  • DOSAGE & ADMINISTRATION

    Place a new, unused saline capsule in the Gailyus nasal washer’s crushing chamber, and keep the foil-side down.
    The optimal water temperature is around 35℃-40℃ (95℉-104℉) for rinsing nasal.

  • PRINCIPAL DISPLAY PANEL

    labellabel

  • INGREDIENTS AND APPEARANCE
    NASAL WASH SALINE 
    sodium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83660-001
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE245 mg  in 9.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 7.1725 mL  in 9.5 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83660-001-1230 in 1 BOX07/28/2023
    1NDC:83660-001-119.5 mL in 1 CAPSULE; Type 0: Not a Combination Product
    2NDC:83660-001-2260 in 1 BOX07/28/2023
    2NDC:83660-001-219.5 mL in 1 CAPSULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/28/2023
    Labeler - Shenzhen Jun&Liang Media Tech Limited (444563661)
    Registrant - Guangdong XINRUNTAO Technology Co., Ltd. (403789850)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong XINRUNTAO Technology Co., Ltd.403789850manufacture(83660-001) , label(83660-001)
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