Label: NASAL SPA NATURAL SEA SALT- sodium chloride spray

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 24, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Natural Sea Salt 9.5 mg/mL

  • PURPOSE

    Purpose

    Nasal Moisturizer

  • INDICATIONS & USAGE

    Uses

    -For cleansing and moisturizing the nose

    -Helps dry nasal congestion caused by

    allergens, irritants, colds, occupational and

    environmental pollutants

  • WARNINGS

    Warnings

    -Do not share between users  -Do not use after the

    expiry date  -Use within 6 months of opening

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions

    -Spray 2 - 3 times into each nostril and inhale through

    your nose  -For best results, use as often as needed

  • DESCRIPTION

    Other Information

    -Store below 25C (77F)

    -Suitable for children and

    adults

  • INACTIVE INGREDIENT

    Inactive Ingredient

    Purified water

  • DESCRIPTION

    For expiry date see top lid.

    Use Nasal Spa Nasal Spray

    to help:

    • nasal congestion
    • dry nose
    • runny clear mucus
    • rinse out allergens and pollutants
    • remove excess mucus
    • dripping sensation in the back of the throat
  • DESCRIPTION

    The patented applicator of

    the Nasal Spa Nasal Spray

    contains an highly effective

    valve and an oligo-

    dynamically active silver coil

    which protects the solution

    and the dosage applied

    against microbial

    congestion.

    The sea salt is manufactured

    in a highly technical

    process (spray-drying)

    harvesting seawater taken

    from an archipelago off

    the coast of France in Europe.

    Compared to standard

    sodium chloride solutions,

    the gentle, isotonic natural

    sea salt solution (0.95%) of

    the Nasal Spa Spray is

    rich in minerals and trace

    elements.

    MADE IN GERMANY

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    NASAL SPA  NATURAL SEA SALT
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70176-100
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE9.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70176-100-011 in 1 CARTON10/29/2015
    120 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 other10/29/2015
    Labeler - NACUR HEALTHCARE LTD (346989317)