Label: ATHOMER PROPOLIS- nasal decongestant spray

  • NDC Code(s): 80897-001-10, 80897-001-35
  • Packager: Nobu Baby LLC
  • 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(s)

    Sodium Chloride (0.9%)

  • Purpose

    Nasal decongestant

  • Use

    • For cleaning the nasal cavity and the removal of the unpleasant mucus.
    • For nasal irrigation
  • Directions

    • For the liquidation and removal of the unpleasant mucus, apply at least 4 sprayings in each nostril up to 4 times per day
    • For preventative daily use, apply 1 to 2 sprayings in each nostril every day
    • Suitable for repeated long-term use
    • Shake well before each use
  • Warnings

    Use only as directed
    The use of this dispenser by more than one person may spread infection
    If you are pregnant or breastfeeding, seek guidance from a healthcare professional

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Other information or comments

    • Store at room temperature between 68° and 77° F (20° to 25°C)
  • Inactive ingredients

    Purified Water, Propolis

  • Package Label - Principal Display Panel

    35 ml NDC: 80897-001-35

    Inner bottle label outer package label

    100 ml NDC: 80897-001-10

    Inner bottle label babyouter package label baby

  • INGREDIENTS AND APPEARANCE
    ATHOMER PROPOLIS 
    nasal decongestant spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80897-001
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80897-001-3535 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/04/2020
    2NDC:80897-001-10100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - Nobu Baby LLC (090064974)
    Establishment
    NameAddressID/FEIBusiness Operations
    STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"499700727manufacture(80897-001)
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