Label: KETTLE NETI POT- sodium bicarbonate, sodium chloride powder, for solution

  • Category: HUMAN OTC DRUG LABEL

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 May 27, 2013

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  • ACTIVE INGREDIENT

    Enter section text here 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

    -Nasal Stuffiness

    -Runny Nose

    -Post nasal drip

    Removes inhaled irritants (dust, pollen)

    Promotes nasal and sinus drainage

    Helps reduce swelling of nasal membranes

  • KEEP OUT OF REACH OF CHILDREN

     Keep out of reach from children

  • WARNINGS

    Warnings

    Stop use and ask a doctor if washing is uncomfortable or symptoms are not relieved

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 4 years and over: use 1-2 packets every 2 hours as needed

    Children under 4 years: consult a doctor

    Consult Instructions for Use for proper use

  • 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


  • INACTIVE INGREDIENT

    Inactive Ingredients

    None

  • INSTRUCTIONS FOR USE

     Instructions for Use:

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

    1. Empty the contents of one Saline Sinus Wash packet into the Classic Neti Pot. First-time users should

    start with 1/2 packet of the 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 proper water. This makes 1/2 cup (4 oz) solution.

    3. Stir thoroughly until dry ingredients have completely dissolved.

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

    Lean over the sink 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 begin to drain out of the left nostril into the

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

    5. When the pot is empty, exhale through both nostrils to clear them of excess mucous 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 sterilized, filtered or previously boiled and leave the pot to air-dry completely.

    The Classic Neti Pot is top-rack dishwasher safe.


  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    KETTLE NETI POT 
    sodium bicarbonate, sodium chloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-752
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE700 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2300 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-752-03100 in 1 CARTON
    11 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2013
    Labeler - Cardinal Health 414, LLC (097537435)