Label: SOFT TIP SQUEEZE BOTTLE SINUS WASH GOOD NEIGHBOR PHARMACY- sodium bicarbonate, sodium chloride kit

  • NDC Code(s): 24385-121-01, 42829-998-00
  • Packager: AMERISOURCE BEGEN
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 17, 2024

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  • PURPOSE

    Purpose

    Nasal Wash

  • ACTIVE INGREDIENT

    Active ingredients

    (in each packet)

    Sodium Bicarbonate USP (700 mg)

    Sodium Chloride USP (2300 mg)

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves symptoms associated with

    sinusitis, cold, flu or allergies

    -Sneezing

    -Nasal Stuffiness

    -Runny nose

    -Post nasal drip

    Removes inhaled irritants (dust, pollen)

    Removes nasal and sinus drainage

    Helps reduce swelling of nasal membranes

    Moisturizes dry nasal passages

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • WARNINGS

    Warnings

    Stop use and ask a doctor if washing is uncomfortable

    or symptoms are not relieved.

    Do not use unfiltered tap water. see instructions inside box for proper water sources

    Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 4 years and over: Use 1-2 packets per 8 fl oz (240 mL) up to every 2 hours as needed.



    Children under 4 years: Consult a physician

    See enclosed instruction sheet for complete directions and proper use.

  • OTHER SAFETY INFORMATION

    Other Information

    -Inspect saline packets for integrity

    -Do not use saline packets if open or torn

    -Protect saline packets from excessive heat and moisture

    -See saline packets or box for lot number and expiration date

    Questions?

    1-888-547-5492

  • INACTIVE INGREDIENT

    Inactive Ingredients

    None

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    SOFT TIP SQUEEZE BOTTLE SINUS WASH  GOOD NEIGHBOR PHARMACY
    sodium bicarbonate, sodium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-121
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-121-011 in 1 KIT; Type 1: Convenience Kit of Co-Package01/09/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 130 PACKET 90000 mg
    Part 1 of 1
    SINUS WASH SALINE REFILLS 
    sodium bicarbonate, sodium chloride powder, for solution
    Product Information
    Item Code (Source)NDC:42829-998
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2300 mg  in 3000 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE700 mg  in 3000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42829-998-003000 mg in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/09/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/09/2022
    Labeler - AMERISOURCE BEGEN (007914906)