Label: INCARVEXX ESSENTIAL- sodium chloride, iodine spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 10, 2023

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  • ACTIVE INGREDIENT

    lodine (0.002%)

    Sodium Chloride (0.9%)

  • PURPOSE

    lodine (0.002%) Antiseptic

    Sodium Chloride (0.9%) Nasal Decongestant

  • Uses

    • For clearing the nasal cavities and the removal of the unpleasant mucus
    • For nasal irrigation
  • Directions

    * Apply 1-4 sprayings into each nostril up to 4 times a day

    * As a prevention use once a day with 2 sprayings

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Warnings

    * Use only as directed

    * The use of the dispenser by more than 1 person may spread infection

  • INACTIVE INGREDIENT

    • Sea water
  • Other information or comments

    * Store at room temperature between 68 and 77°F (20-25 °C)

  • PRINCIPAL DISPLAY PANEL

    NDC: 80897-030-35

    Outer package label

    bottle label

  • INGREDIENTS AND APPEARANCE
    INCARVEXX ESSENTIAL 
    sodium chloride, iodine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80897-030
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE20 ug  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80897-030-351 in 1 CARTON06/22/2021
    135 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/22/2021
    Labeler - Nobu Baby LLC (090064974)
    Establishment
    NameAddressID/FEIBusiness Operations
    STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"499700727manufacture(80897-030)
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