Label: SINUS WASH PRE MIXED READY TO USE RITE AID- 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 December 18, 2024

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 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

    RA_RTU-01

  • INGREDIENTS AND APPEARANCE
    SINUS WASH PRE MIXED READY TO USE  RITE AID
    sodium chloride, sodium bicarbonate kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0472
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0472-81 in 1 KIT; Type 1: Convenience Kit of Co-Package01/16/202212/31/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 3000 mg
    Part 21 BOTTLE 240 mg
    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 CHLORIDE2300 mg  in 3000 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM BICARBONATE700 mg  in 3000 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 other01/16/2019
    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 BICARBONATE700 mg  in 3000 mg
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE2300 mg  in 3000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 KIT
    1240 mg in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/16/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/16/201912/31/2024
    Labeler - RITE AID CORPORATION (014578892)