Label: STERILE SALINE KIDS MIST PEDIAMEDS- sodium chloride spray

  • NDC Code(s): 42829-003-12
  • 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 August 8, 2022

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  • Active Ingredient

    Sodium Chloride 0.9%

    Sterile, Hypertonic Saline Solution,

    Sodium Bicarbonate to adjust pH

  • Purpose

    Nasal Wash

  • Uses

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

    Directions
    Children 6 months and over: Use as often as needed
    Children under 6 months: Consult a physician

  • 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

    1

  • INGREDIENTS AND APPEARANCE
    STERILE SALINE KIDS MIST  PEDIAMEDS
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42829-003
    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:42829-003-12127 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/13/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/13/2022
    Labeler - ASCENT CONSUMER PRODUCTS, INC. (078396381)
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