Label: SINUCLEANSE NETI-POT- sodium bicarbonate, sodium chloride kit

  • NDC Code(s): 42829-401-01, 42829-402-30
  • Packager: ASCENT CONSUMER PRODUCTS, INC.
  • 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 February 22, 2021

If you are a consumer or patient please visit this version.

  • 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 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

  • ACTIVE INGREDIENT

    Active ingredients

    (in each packet)

    Sodium Bicarbonate USP (700 mg)

    Sodium Chloride USP (2300 mg)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    None

  • INSTRUCTIONS FOR USE

    Instructions for Use of the SinuCleanse Neti Pot

    Directions: Read through entire section before using for the first time.

    1. Empty the contents of one SinuCleanse Saline Wash packet into the

    SinuCleanse Neti Pot. First-time users should start with 1/2 packet of

    the SinuCleanse dry ingredients. As you become more accustomed to

    the system, work up to using 1 full packet. Additional packets may be

    purchased from your nearest pharmacy.

    2. Fill the pot halfway or to the middle of the indentation with a proper water source.*

    This makes 1/2 cup (4 oz. ) solution.

    3. Stir thoroughly until dry ingredients have completely dissolved.

    4. Proper head position allows solution to flow through the nose by gravity.

        - Lean over the sink with your head bent down so you are looking directly into the basin.

        Holding the pot in your right hand, gently insert the spout into your right nostril so that it

        forms a comfortable seal.

        - Rotate your head so that the right nostril is directly above the left. The forehead should

        remain higher than the chin. Raise the handle of the pot so that the solution enters the right

        nostril. In a few moments, the solution will begn to drain out the left nostril into the sink.

        Do not inhale or "snort" solution into the nose - breathe through your mouth.

    5. When the pot i empty, exhale through both nostrils to clear them

    of excess mucus and solution. Gently blow your nose into a tissue.

    6. Repeat the procedure on the other side.

    7. Thoroughly rinse the pot after each use with water that has

    been distilled, sterilized, filtered or previously boiled and leave the

    pot to air dry completely. The SinuCleanse Neti Pot is top-rack dishwasher safe.

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SINUCLEANSE NETI-POT 
    sodium bicarbonate, sodium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42829-402
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42829-402-301 in 1 KIT; Type 1: Convenience Kit of Co-Package02/01/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 130 PACKET 90000 mg
    Part 1 of 1
    SINUCLEANSE 
    sodium bicarbonate, sodium chloride powder, for solution
    Product Information
    Item Code (Source)NDC:42829-401
    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:42829-401-013000 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 other04/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2015
    Labeler - ASCENT CONSUMER PRODUCTS, INC. (078396381)