Label: SINUCLEANSE- sodium bicarbonate, sodium chloride powder, for solution

  • NDC Code(s): 42829-408-60
  • Packager: ASCENT CONSUMER PRODUCTS, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 20, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients

    (in each packet)

    Sodium Bicarbonate USP 700 mg

    Sodium Chloride USP 2300 mg

  • PURPOSE

    Purpose

    Nasal Wash

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves symptoms associated with

    sinusitis, cold, flu or allergies:

    -Sneezing

    -Runny nose

    -Nasal stuffiness

    -Post nasal drip

    -Removes inhaled irritants (dust, pollen)

    -Promotes nasal and sinus drainage

    -Helps reduce swelling of nasal membranes

    -Moisturizes dry nasal passages

  • 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.

  • WHEN USING

    When using this product:

    -Use by only one person

    -Wash with soap and water after each use

    -Top rack of dishwasher safe

    -Do not heat in microwave

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 4 years and over:      use 1/2 - 1 packet per 4 fl oz (120 mL)up to every two 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 # and expiration date

  • INACTIVE INGREDIENT

    Inactive Ingredients

    None

  • QUESTIONS

    Questions?

    1-888-547-5492

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SINUCLEANSE 
    sodium bicarbonate, sodium chloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42829-408
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE22.2 mg  in 100 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE77.8 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42829-408-6060 in 1 CARTON02/01/2015
    13000 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2015
    Labeler - ASCENT CONSUMER PRODUCTS, INC. (078396381)
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