Label: ATHOMER BABY- nasal decongestant 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(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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Other information

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

    Sea Water

  • Package Label - Principal Display Panel

    100 ml NDC: 80897-002-10

    Inner bottle label outer package label

  • INGREDIENTS AND APPEARANCE
    ATHOMER BABY 
    nasal decongestant spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80897-002
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80897-002-101 in 1 CARTON11/05/2020
    1100 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 other11/05/2020
    Labeler - Nobu Baby LLC (090064974)
    Establishment
    NameAddressID/FEIBusiness Operations
    STERGIOULAS, STYLIANOS, & CO. E.E. "PHARMACOSMETIC - DIAFARM"499700727manufacture(80897-002)
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