Label: CVS- sodium chloride, sodium bicarbonate kit

  • 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 March 25, 2016

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

  • ACTIVE INGREDIENT

    Active ingredients

    (in each prefilled bottle)

    Sodium Bicarbonate USP 700 mg }

    Sodium Chloride USP 2300 mg }

    Active ingredients

    (in each packet)

    Sodium Bicarbonate USP 700 mg }

    Sodium Chloride USP 2300 mg }

  • PURPOSE

    Purpose

    Nasal Wash

    Purpose

    Nasal Wash

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves symptoms associated with sinusitis, cold, flue 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 ear.

    When using this product:

    -Use by only one person

    -Wash with soap and water after each use

    -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 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
    • Do not use if printed foil seal under cap on pre-filled bottle is broken or missing
    • Protect saline packets from excessive heat and moisture
    • See saline packets or box for lot number and expiration date
  • INACTIVE INGREDIENT

    Inactive ingredients

    (in each prefilled bottle)

    Purified Water USP, Benzalkonium Chloride USP (Preservative)

    Inactive ingredient

    (in each packet)

    none

  • QUESTIONS

    Questions?

    1-888-547-5492

  • INSTRUCTIONS FOR USE

    Sinus Wash
    Pre-Filled Ready to Use
    Saline Sinus Wash Kit
    Instructions
    DO NOT
    SINUS WASH
    WITH UNFILTERED
    TAP WATER.
    See important note*
    for proper water
    sources.
    Read through entire instruction sheet
    before using for the fi rst time.
    * IMPORTANT NOTE
    Do not sinus wash with unfi ltered tap water. Use either distilled, or
    sterile, or fi ltered (using a fi lter with an absolute pore size of 1 micron or
    smaller) or previously boiled water (boil water 1 minute or 3 minutes if at
    elevations above 6,500 feet, then allow to cool to body temperature).
    Instructions for Use of the Ready to Use
    Sinus Wash Kit (pre-filled with solution)
    Read through entire section.
    1. Wash your hands and remove cap and foil safety seal from the top of
    the pre-filled bottle.
    2. Assemble white cap and tube and then place on pre-filled bottle and
    tighten securely.
    3. Lean over the sink with your head bent down so you are looking directly
    into the basin. Place the tip of the cap up to the right nostril and gently
    insert the tip so that it forms a comfortable seal. Aim the tip at the back
    of your head, not at the top of your head.
    4. Squeeze the bottle gently so that the solution enters the right nostril. Do not
    inhale or “snort” the solution into the nose – breathe through your mouth.
    5. In a few moments, the solution will begin to drain out of the left
    nostril. Continue to squeeze the bottle gently until you have used
    approximately half of the solution.
    6. Remove the tip of the bottle from your nostril, then exhale through both
    nostrils to clear them of excess mucus and solution. Gently blow your
    nose into a tissue.
    7. Repeat the procedure on the left nostril with the remaining solution.
    8. A small amount of solution will remain at the bottom of the bottle.
    Discard the remaining solution.
    9. Thoroughly rinse the bottle after each use with water that has been
    either distilled, sterilized, filtered or previously boiled and leave the
    bottle open to air dry completely.
    10. Bottle, tube and cap may be reused with included packets. See
    instructions that follow.
    Isotonic Solution
    Hypertonic Solution
    1 Saline Packet per
    8 fl oz. (240 mL)
    2 Saline Packets per
    8 fl oz. (240 mL)
    Refill instructions for the Ready to Use
    Sinus Wash Kit (with saline packets)
    Read through entire section.
    The Ready to Use Sinus Wash Kit 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.
    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.
    1. Wash your hands and make sure the bottle has been rinsed with water
    that has been either distilled, sterilized, filtered or previously boiled.
    2. Pour the pre-mixed saline dry ingredients into the Squeeze Bottle.
    First-time users should start with 1 packet of the saline dry ingredients
    to make an isotonic solution. As you become more accustomed to
    the system, work up to using 2 full packets for a hypertonic solution.
    Additional packets may be purchased from your nearest pharmacy.
    3. Fill the bottle to the 8 oz line with proper water*.
    4. Tighten the cap on the bottle securely, place one finger over the tip
    of the cap and gently shake the bottle until the dry ingredients have
    completely dissolved.
    5. Lean over the sink with your head bent down so you are looking directly
    into the basin. Place the tip of the cap up to the right nostril and gently
    insert the tip so that it forms a comfortable seal. Aim the tip at the back
    of your head, not at the top of your head. (continued on back)
    Hints for a more comfortable nasal wash:
    • Begin using the Sinus Wash System slowly – especially with children. A full
    pot or bottle 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 packet of dry ingredients per
    pot or bottle. Gradually work up to using the solution at full strength using 2
    full packets per bottle. Do not use less than 1 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

    copy of label

  • INGREDIENTS AND APPEARANCE
    CVS 
    sodium chloride, sodium bicarbonate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-867
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-867-031 in 1 KIT07/01/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE 3 g
    Part 21 PACKET 3000 mg
    Part 1 of 2
    CVS 
    sodium bicarbonate, sodium chloride solution
    Product Information
    Item Code (Source)NDC:59779-865
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE22.2 mg  in .1 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE77.8 mg  in .1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    1NDC:59779-865-00240 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2016
    Part 2 of 2
    CVS 
    sodium bicarbonate, sodium chloride powder
    Product Information
    Item Code (Source)NDC:59779-408
    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
    11 in 1 KIT
    1NDC:59779-408-013000 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 other07/01/2014
    Labeler - CVS Pharmacy (062312574)