Label: SINUCLEANSE STERILE SALINE MIST DAILY CARE- sodium chloride spray

  • NDC Code(s): 42829-504-45, 42829-504-75
  • Packager: ASCENT CONSUMER PRODUCTS, INC
  • 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 January 8, 2022

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  • Active Ingredient

    Sodium Chloride 0.9%

    Sterile, Isotonic Saline Solution,

    Sodium Bicarbonate USP to adjust pH

  • Purpose

    Nasal Moisturizer

  • Uses

    • Nasal congestion
    • Removes inhaled irritants (dust, dirt, pollen)
    • Moisturizes dry nasal passages
  • Directions

    Adults and children 4 years and over: Use as often as needed

    Children under 4 years: Consult a physician

    See directions on can for complete instructions

  • Warnings

    Warnings

    Use of this product by more than one person may spread infection
    Contents under pressure
    Do not puncture or incinerate
    Avoid spraying in eyes

  • Keep out of reach of chlidren.

  • Other Information

    Store between 59 and 86 degree F

  • Inactive ingredients

    Purfied Water

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  • Saline Nasal Spray product label

    12

  • INGREDIENTS AND APPEARANCE
    SINUCLEANSE STERILE SALINE MIST DAILY CARE 
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42829-504
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42829-504-45127 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/08/2022
    2NDC:42829-504-75213 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/08/2022
    Labeler - ASCENT CONSUMER PRODUCTS, INC (078396381)