WALGREENS FILTERED SQUEEZE SINUS WASH SYSTEM (SODIUM CHLORIDE, SODIUM BICARBONATE) KIT [WALGREEN COMPANY]

WALGREENS FILTERED SQUEEZE SINUS WASH SYSTEM (SODIUM CHLORIDE, SODIUM BICARBONATE) KIT [WALGREEN COMPANY]
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NDC 0363-0802-00, 0363-1406-30, 307073877636
Set ID de88aa98-73cf-4bed-9d6d-37e8461c2925
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number
  • 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.

    When used with tap water see instructions inside box

    for proper water sources.


    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 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 no. and expiration date
  • INACTIVE INGREDIENT

    Inactive ingredients: none

  • QUESTIONS

    Questions?

    1-888-547-5492

  • INSTRUCTIONS FOR USE

    Filter Data
    Model #’s:
    91-40630, 97-40630, 98-40630
    Manufacturer:
    Ascent Consumer Products Inc.
    Melville NY 11737
    888-547-5492
    Distributed by:
    See Box for Information
    Filter Type:
    Mechanical Cyst Reduction Filter
    Maximum Operating Temperature:
    100 degrees Fahrenheit
    Maximum Working Pressure:
    5 psi
    Maximum Service Life:
    50 gallons
    This product has been tested and certified to meet NSF/ANSI Standard
    53, a drinking water standard, for cyst reduction of 99.95% and to be
    lead free.
    For more information from the Centers for Disease Control and Prevention (CDC)
    on water filters and sinus washing visit the CDC web site at: http://www.cdc.gov.
    Micro-Filtered
    Sinus Wash System
    Please read instructions thoroughly before
    using and keep for future reference.

    NEW!
    BUILT IN WATER
    FILTER
    About the Micro-Filtered Sinus Wash System
    The Micro-Filtered Sinus Wash System is a revolutionary new
    product that makes receiving the proven benefits of sinus
    washing easier than ever. The built in water filter meets the
    CDC recommendation for sinus washing with tap water*. This
    provides peace of mind, while also eliminating the cost of
    bottled water or the inconvenience of boiling and pre-filtering
    tap water. It also allows for easier temperature control of the
    saline solution for a soothing and more comfortable sinus wash

    The patent pending Micro-Filtered System incorporates
    additional innovations to maximize the comfort and
    convenience of sinus washing:
    • Inverted filter technology with anti-backflow valve uses a
    combination of gravity and positive pressure to provide an
    easy to control and comfortable flow of the saline solution.
    • Ergonomically designed bottle and soft nasal tip are
    comfortable to use and easy to clean.

    Frequently asked questions and important information
    about the Micro-Filtered Sinus Wash System Warning: Do not use Micro-Filtered System if nasal passages are
    completely blocked.
    Preparing the Micro-Filtered System for first use
    Before first use rinse the bottle with warm tap water and empty. Next fill bottle
    with warm tap water and place cap on bottle and tighten securely. Holding the
    assembled bottle and cap over the sink, invert so comfort tip faces up and squeeze
    bottle several times until bottle is empty and no water flows from the comfort tip.
    Repeat the filling and emptying process two additional times. The Micro-Filtered
    System is now ready for use.
    What type of water can be used in the Micro-Filtered System?
    In addition to distilled water or commercially bottled water the Micro-Filtered System
    can be used with tap water. WARNING: The Micro-Filtered System is intended as a
    final filter for tap water that is known to be safe for drinking.
    How do I clean the Micro-Filtered System?
    Do not clean any part of the Micro-Filtered System in the dishwasher.
    Cleaning the bottle: Rinse the bottle out with water after each use and allow to dry.
    Cleaning the comfort tip: Remove tip and clean with soap and water after each use.
    Replace tip after cleaning.
    Cleaning the cap: The outside of the cap can be rinsed with water and dried.
    Can I share the Micro-Filtered System with friends and family?
    The Micro-Filtered System is intended for individual use and not to be shared.

    How do I clean the Micro-Filtered System?
    Do not clean any part of the Micro-Filtered System in the dishwasher.
    Cleaning the bottle: Rinse the bottle out with water after each use and allow to dry.
    Cleaning the comfort tip: Remove tip and clean with soap and water after each use.
    Replace tip after cleaning.
    Cleaning the cap: The outside of the cap can be rinsed with water and dried.

    Should I use an Isotonic or Hypertonic solution?
    The Micro-Filtered System can be used with the enclosed saline packets to make either
    an Isotonic or Hypertonic solution. An Isotonic solution has a salt concentration similar
    to your body and some people find this more comfortable to use. A Hypertonic
    solution is more concentrated, similar to the salt concentration of ocean water. Both
    are beneficial to your sinus and nasal health.
    Check with the guide below or consult with your physician for best use.

    Check with the guide below or consult with your physician for best use.
    Isotonic Solution 1 Saline Packet per
    8 fl oz
    Hypertonic Solution
    2 Saline Packets per
    8 fl oz
    Helpful hints for a more comfortable sinus wash experience:
    • Begin using the Micro-Filtered System slowly – especially with children. A full
    bottle of solution is not necessary to receive the full benefit.
    • If the solution is too warm or too cold, the Sinus Wash will be uncomfortable.
    • If stinging or irritation occurs, try using 1 packet of dry ingredients per
    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 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.

    Instructions for Use:
    1. Wash your hands and make sure the Micro-Filtered System has been prepared
    according to the instructions above before first use.
    2. Pour the contents of the saline packet(s) into the bottle. First-time users should start
    with 1 packet to make an Isotonic solution. As you become more accustomed to
    using the system, you may work up to using 2 full packets for a Hypertonic solution.
    Additional packets may be purchased online or from your nearest pharmacy.
    3. Fill the bottle with warm tap water to the 8 oz mark indicated on the bottle. Test
    water temperature before using.
    7. 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.
    8. Remove the comfort tip from your nostril, then exhale through both nostrils to clear
    them of excess mucus and solution. Gently blow your nose into a tissue.
    9. Repeat the procedure on the left nostril with the remaining solution.
    10. When finished hold the system inverted over sink and squeeze several times to
    remove solution remaining in cap.
    11. Holding the cap assembly over the sink unscrew filter (B) by turning the white ring on bottom
    of cap counter clockwise while holding cap (A). Empty any remaining solution into the sink
    and allow to dry. Reassemble the filter making sure the black O-ring (C) is seated above the
    filter base threads as shown in the illustration below. After each use please clean system.
    Clean the bottle: Rinse the bottle out with water and allow to dry.
    Clean the comfort tip: Remove tip and clean with soap and water and reinstall.
    Clean the cap: The outside of the cap can be rinsed with water and dried.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WALGREENS FILTERED SQUEEZE SINUS WASH SYSTEM 
    sodium chloride, sodium bicarbonate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1406
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1406-301 in 1 KIT07/01/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 3000 mg
    Part 21 CARTON
    Part 1 of 2
    WELL AT WALGREENS 
    sodium bicarbonate, sodium chloride powder, for solution
    Product Information
    Item Code (Source)NDC:0363-0802
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE700 mg  in 3000 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2300 mg  in 3000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 in 1 KIT
    1NDC:0363-0802-003000 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
    Part 2 of 2
    FILTERED SQUEEZE SINUS WASH SYSTEM 
    applicator, ent
    Product Information
    Item Code (Source)GS1:30707387763634
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    1GS1:3070738776361 in 1 CARTON; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceKCJ07/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2015
    Labeler - Walgreen Company (008965063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sugar Foods Corporation062829072manufacture(0363-0802)

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