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

  • NDC Code(s): 42829-401-01
  • 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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  • PURPOSE

    Purpose

    Nasal Wash

  • 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 -1 packet  per 4 fl oz (120 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.

  • SPL UNCLASSIFIED SECTION

    Important Note: SinuCleanse Saline Packets contain 3 grams of

    pharmaceutical grade salt. Using the calculations in the chart, you can

    prepare either an Isotonic or Hypertonic Solution. Since contents of other

    manufacturer's Salt Packets may vary, please check with their directions

    for Isotonic or Hypertonic use.

  • ACTIVE INGREDIENT

    Active ingredients

    (in each packet)

    Sodium Bicarbonate USP (700 mg)

    Sodium Chloride USP (2300 mg)

  • INACTIVE INGREDIENT

    Inactive ingredients

    None

  • 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

  • QUESTIONS

    Questions?

    1-888-547-5492

  • OTHER SAFETY INFORMATION

    -See enclosed instruction sheet for complete directions and proper use


  • 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:42829-401
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE700 mg  in 3000 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2300 mg  in 3000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42829-401-013000 mg in 1 PACKET; Type 0: Not a Combination Product02/01/2015
    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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