Label: SINUCLEANSE NASAL DRIP- sodium chloride gel

  • NDC Code(s): 42829-407-10
  • Packager: ASCENT CONSUMER PRODUCTS, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 8, 2022

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  • Active Ingredient

    Sodium Chloride 0.9%

    Saline Nasal Gel,

    Sodium Bicarbonate to adjust pH

  • Purpose

    Nasal Moisturizer

  • Uses

    • Provides moisture to soothe and hydrate dry nasal passages caused by Indoor heat, dry climate, air travel, high altitude, oxygen use, CPAP machineuse
  • 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 complere instructions

    For nasal use only.

    Before use, expel a shoet stream of mist into the air. Insert tip of nozzle into one nostril and press down on the textured area at the base of the nozzle so that a gentle mist coats nasal passages. Blow your nose very gently to clear the mucus out. Repeat for the other nostriil.

    To flush and irrigate, tilt head to the side over sink. Insert top of nozzle into the top nostril, pressing down on the textured area at the base of the nozzle so that a gentle mist fills sinus passages and flows out the opposite nostril. Repeat in other nostril.

    Wipe nozzle after each use.

  • Warnings

    Warnings

    -Stop use and ask a doctor if use is uncomfortable or dryness persists

    -Do not use if allergic to any of the ingredients

    -Do not use if the safety seal is missing or broken

    - For nasal use only, do not use for dry mouth

  • Keep out of reach of chlidren.

  • Other Information

    -Store in cool dry place and protect freezing

    -See box for lot number and expiration date

  • Inactive ingredients

    aloe vera, allantoin, glycerin, propylene glycol, purified water USP, sodium hyaluronate, benzalkonium chloride

  • QUESTIONS ?

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  • Product label

    Gel

  • INGREDIENTS AND APPEARANCE
    SINUCLEANSE NASAL DRIP 
    sodium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42829-407
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42829-407-1030 mL 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)
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