Label: CVS- sodium chloride, sodium bicarbonate kit

  • NDC Code(s): 69842-324-01, 69842-349-10
  • Packager: CVS Pharmacy, 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 June 7, 2020

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

  • 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 reduced.

    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 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 2 hours as needed

    Children under 4 years:  Consult a physician

    See enclosed instruction sheet for complete instructions 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
  • INACTIVE INGREDIENT

    Inactive ingredients: none

  • QUESTIONS

    Questions?

    1-888-547-5492

  • INSTRUCTIONS FOR USE

    *IMPORTANT NOTE
    Do not sinus wash with unfiltered tap water. Use either distilled, or sterile, or filtered (using a filter with an absolute pore size of 1 micron orsmaller) or previously boiled water (boil water 1 minute or 3 minutes if at elevations above 6,500 feet then allow to cool to bodytemperature).

    Sinus Wash Compact Neti Pot Instructions
    Read through entire instruction
    sheet before using for the first time.

    DO NOT SINUS WASH
    WITH UNFILTERED TAP WATER.
    See important note* for proper water sources.

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

    Should I use an Isotonic or Hypertonic Solution?

    Any Sinus Wash Device can be used with the enclosed Saline packets to make either an Isotonic or Hypertonic solution. Check with the guide below or consult with your physician for best use.

    Isotonic Solution 1/2 Saline Packet per 4 fl oz. (120 mL)

    Hypertonic Solution 1 Saline Packets per 4 fl oz. (120 mL)

    An Isotonic solution creates a mild, less concentrated salt solution of 9 mg of Sodium Chloride per mL of water, which has a similar salt concentration of your body and may be more comfortable to use for some people initially than a more concentrated Hypertonic solution.

    A Hypertonic solution creates a higher, more concentrated salt solution which is similar to the salt content of ocean water.

    What is the Sinus Wash System?
    The Sinus Wash System is an all natural and medically proven method for relieving allergies, nasal congestion, discomfort caused by dry air, sinus infections, rhinitis of pregnancy and
    soothing irritated nasal passages. It gently washes away mucus buildup from the nose and improves breathing.
    Because it is gentle, the system can be used up to every 2 hours as needed. Some people use it as routinely as they brush their teeth while others use it only on days when they need it.

    ACP No. 99-40330-205-00

    Instructions for Use of the Compact Neti Pot:
    Directions & Dosage: Read through entire section before using for the first time.

    1. Pour the pre-mixed saline dry ingredients into the Compact Neti Pot. First-time users should start with 1/2 packet of the saline 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 to the 4 oz. line with proper water*. This makes 1/2 cup (4 oz.) of solution.

    3. Stir thoroughly until the 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 Neti 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 Neti Pot so that the solution enters the right nostril. In a few moments, the solution will begin 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 Neti Pot is 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 left nostril.

    7. Thoroughly rinse the Neti Pot after each use with water that has been distilled, sterilized, filtered or previously boiled and leave the pot open to air dry completely. The Compact Neti Pot is top-rack dishwasher safe.

    Hints for a more comfortable nasal wash:
    • Begin using the Sinus Wash System slowly – especially with children. A full pot of solution on each side is not necessary to receive the full benefit.
    • If the solution is too warm or too cold, the nasal wash will be uncomfortable.
    • If stinging or irritation occurs, try using 1/2 packet of dry ingredients per pot. Gradually work up to using the
    solution at full strength using 1 full packet per pot. Do not use less than 1/2 packet.
    • If you experience ear discomfort after use, try to blow your nose more gently after the wash. If the problem persists, the openings of your Eustachian tubes may be particularly wide and use of the system should be discontinued.
    • Breathe continuously through the mouth when using the Sinus Wash System to avoid solution draining from the back of the nose into the mouth.
    • Some people experience irritation of the skin just inside the nostrils with repeated nasal washing. Applying a thin layer of aloe to the inside of the nostrils before or after the nasal wash will be soothing.

  • PRINCIPAL DISPLAY PANEL

    IMAGE

  • INGREDIENTS AND APPEARANCE
    CVS 
    sodium chloride, sodium bicarbonate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-349
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-349-101 in 1 KIT03/25/2016
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 3000 mg
    Part 1 of 1
    CVS 
    sodium bicarbonate, sodium chloride powder
    Product Information
    Item Code (Source)NDC:69842-324
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE22.8 mg  in 100 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE77.8 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 KIT
    1NDC:69842-324-013000 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 other06/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/25/2016
    Labeler - CVS Pharmacy, Inc. (062312574)