Label: LEADER SINUS WASH SALINE REFILL PACKETS- sodium bicarbonate, sodium chloride powder, for solution

  • NDC Code(s): 70000-0270-1, 70000-0270-2
  • Packager: Cardinal Health, 110 dba LEADER
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 17, 2024

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  • 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

  • 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 for proper water sources.

    • Do not use if nasal passages are completely blocked or if you have an ear infection or blocked ears.

  • 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 sheetfor 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 # and expiration date
  • QUESTIONS

    Questions?

    1-888-547-5492

  • PATIENT PACKAGE INSERT

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  • PATIENT PACKAGE INSERT

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    None

  • PRINCIPAL DISPLAY PANEL

    image description

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LEADER SINUS WASH SALINE REFILL PACKETS 
    sodium bicarbonate, sodium chloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0270
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE700 mg  in 3 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2300 mg  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0270-130 in 1 CARTON04/01/2013
    13 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:70000-0270-2100 in 1 CARTON04/01/2013
    23 g 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
    Labeler - Cardinal Health, 110 dba LEADER (063997360)
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