Label: ATHOMER BABY- sodium chloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 4, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Purified Sea Water    		Purpose
    Nasal decongestant
  • Uses

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

    • For external use only
    • 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
  • 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
  • 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

    Purified Water
    Propolis

  • PREGNANCY OR BREAST FEEDING

  • STOP USE

  • WHEN USING

  • DOSAGE & ADMINISTRATION

  • PRINCIPAL DISPLAY PANEL - 100 mL carton

    ATHOMER

    baby

    STERILE ISOTONIC
    SEA WATER
    SPRAY

    NASAL HYGIENE
    AND CLEANNESS

    PROPOLIS

    ABSOLUTELY
    NATURAL PRODUCT

    100 mL

    Carton

  • INGREDIENTS AND APPEARANCE
    ATHOMER BABY 
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54753-003
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54753-003-101 in 1 CARTON
    1100 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/14/2013
    Labeler - PHARMACOSMETIC-DIAFARM (078683688)
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