Label: CVS- sodium bicarbonate, sodium chloride solution

  • 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 15, 2016

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  • ACTIVE INGREDIENT

    Active ingredients:

    Sodium Bicarbonate USP 700 mg

    Sodium Chloride USP 2300 mg

  • PURPOSE

    Ready to Use

    SINUS WASH

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Purified Water ISP

    Benzalkonium Chloride USP (Preservative)

  • WARNINGS

    Warning: When Using Bottle With

    Refill Packets Do Not Use Unfiltered

    Tap Water.

    Use either distilled, or sterile, or filered

    water (using a filter 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 6500 feet

    then allow to cool to body temperature).

  • QUESTIONS

    Questions or Comments

    1-888-547-5492

  • DESCRIPTION

    See Instruction Sheet Inside Box

    for Complete Directions

    and Proper Use

  • 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 first time.

    What is the Sinus Wash Kit?

    The Sinus Wash Kit 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, it 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.

    * IMPORTANT NOTE

    Do not sinus wash with unfiltered tap water. Use either distilled, or

    sterile, or fi ltered (using a filter 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).

    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

  • KEEP OUT OF REACH OF CHILDREN

    See Instruction Sheet Inside Box

  • DOSAGE & ADMINISTRATION

    See Instruction Sheet Inside Box

  • INDICATIONS & USAGE

    See Instruction Sheet Inside Box

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    CVS 
    sodium bicarbonate, sodium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    1NDC:59779-865-00240 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/01/2016
    Labeler - CVS Pharmacy (062312574)