Label: WELL AT WALGREENS- sodium bicarbonate, sodium chloride 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 May 30, 2015

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  • 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)

    Removes nasal and sinus drainage

    Helps reduce swelling of nasal membranes

    Moisturizes dry nasal passages

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • 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

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 4 years and over: Use 1-2 packets per 8 fl oz (240 mL) up to every two hours as needed.



    Children under 4 years: Consult a physician

    See enclosed instruction sheet for complete directions and proper use.

  • INSTRUCTIONS FOR USE


    Instructions for Use of the Squeeze Bottle:

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

    1. Remove the cap from the squeeze bottle.

    2. Pour the pre-mixed saline dry into the Squeeze Bottle. First-time users

    should start with 1 packet of the saline dry ingredients. As you become more accustomed to the system, work up to using 2 full packets,

    Additional packets may be purchased from your nearest pharmacy.

    3. Fill the bottle with proper water* leaving approximately 1/2 inch of air at the top of the bottle.

    This makes 1 cup (8 oz) of solution.

    4. Tighten the cap on the bottle securely, place one finger over the tip of the cap and and gently shake the bottle until

    the dry ingredients have completely dissolved.

    5. Lean over the sink with your head bent so you are looking directly 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.

    6. Squeeze the bottle gently so that the solution enters the right nostril. Do not inhale or "snort" the solution into your nose - breathe through your mouth.

    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 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.

    9. Repeat the procedure on the left nostril with the remaining solution.

    10. A small amount of the solution will remain in the bottom of the bottle. Discard the remaining solution.

    11. Thoroughly rinse the bottle after each use with water that has been distilled, sterilized,

    filtered or previously boiled and leave the bottle open to air dry completely. The Squeeze Bottle is

    top-rack dishwasher safe.

  • ACTIVE INGREDIENT

    Active ingredients

    (in each packet)

    Sodium Bicarbonate USP (700 mg)

    Sodium Chloride USP (2300 mg)

  • INACTIVE INGREDIENT

    Inactive Ingredients

    None

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    WELL AT WALGREENS  
    sodium bicarbonate, sodium chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0405
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0405-301 in 1 KIT; Type 0: Not a Combination Product
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 130 PACKET 90000 mg
    Part 1 of 1
    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 CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2300 mg  in 3000 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37, BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE700 mg  in 3000 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0802-003000 mg in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2013
    Labeler - Walgreen Company (008965063)