Label: MARIMER HYPERTONIC SEAWATER NASAL- seawater nasal spray spray

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

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated August 2, 2021

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  • DOSAGE & ADMINISTRATION

    Marimer Hypertonic is recommended for children and adults for the cleansing and the decongestioning of the nasal airways, in particular in case of cold and sinusitis.

  • INACTIVE INGREDIENT

    water

  • INDICATIONS & USAGE

    1.for the cleansing of the nasal airways
    2.for the decongestion of the blocked nose,
    3.in complement to the treatments of ENT disorders.

  • ACTIVE INGREDIENT

    2.2% sodium chloride

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OFTHE SIGHT AND REACH OF CHILDREN

  • PURPOSE

    recommended for children and adults for the cleansing

  • STORAGE AND HANDLING

    Do not expose to temperatures exceeding 50°C/122°F

  • WARNINGS

    May burst if heated.Keep away from heat, sparks, open flames, hot surfaces and any other sources of ignition. No smoking. Do not pierce or burn, even after use.Protect from sunlight. Do not expose to temperatures exceeding 5o°C/122°F. KEEP OUT OFTHE SIGHT AND REACH OF CHILDREN. Do not use after the expiry date indicated on the box.

  • PRINCIPAL DISPLAY PANEL

    0201

  • INGREDIENTS AND APPEARANCE
    MARIMER HYPERTONIC SEAWATER NASAL 
    seawater nasal spray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82138-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE2.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82138-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/03/2021
    Labeler - LABORATOIRES GILBERT (262619455)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATOIRES GILBERT262619455manufacture(82138-001)
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