CVS SINUS WASH (SODIUM CHLORIDE, SODIUM BICARBONATE) KIT [DENISON PHARMACEUTICALS, LLC]

CVS SINUS WASH (SODIUM CHLORIDE, SODIUM BICARBONATE) KIT [DENISON PHARMACEUTICALS, LLC]
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NDC 0295-4807-28
Set ID 82837451-6dab-2197-e053-2991aa0aa80a
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    Active Ingredients

    (in each prefilled bottle)

    Sodium Bicarbonate USP 700 mg

    Sodium Chloride USP 2300 mg

  • ACTIVE INGREDIENT

    Active ingredients

    (in each packet)

    Sodium Bicarbonate USP 700 mg

    Sodium Chloride USP 2300 mg

  • PURPOSE

    Purpose

    Nasal Wash

  • 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
    • 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

    Prior to first use see enclosed instruction sheet for complete directions

  • 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

    (in each prefilled bottle)

    Purified Water USP, Benzalkonium Chloride USP (Preservative)

    Inactive ingredients

    (in each packet)

    None

  • QUESTIONS

    Questions?

    1-888-547-5492

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CVS SINUS WASH 
    sodium chloride, sodium bicarbonate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-4807
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-4807-281 in 1 KIT; Type 1: Convenience Kit of Co-Package02/22/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 3000 mg
    Part 21 BOTTLE 240 g
    Part 1 of 2
    SINUS WASH PACKET 
    sodium bicarbonate, sodium chloride powder
    Product Information
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE77.8 mg  in 100 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE22.8 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    13 in 1 KIT
    13000 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 other03/15/2019
    Part 2 of 2
    SINUS WASH PREFILLED BOTTLE 
    sodium bicarbonate, sodium chloride solution
    Product Information
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE22.2 mg  in 0.1 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE77.8 mg  in 0.1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    1240 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 other03/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/22/2019
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(0295-4807)

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