Label: BREATHE THE SEA ALL-NATURAL SEAWATER- sodium chloride spray

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

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Drug Label Information

Updated February 17, 2012

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  • PURPOSE

    USES

    Helps dry congestion related to acute and chronic nasal stuffiness due to irritants, colds, occupational, environmental and home allergens. Provides comfort to congested nasal passages.

  • DIRECTIONS

    Tilt head forward, spray 2-3 times in each nostril directing spray upward and outward toward ear and away from center of nose. Blow nose. For a more thorough cleansing procedure see the Vanderpool Technique ™ and video demonstration at www.BreatheTheSea.com.

  • PRECAUTIONS

    Do not use with children under 6 years of age except as directed by a physician.

    Use of this dispenser by more than one person may spread infection. Avoid spraying in eyes.

  • CAUTION

    Contents under pressure. Do not puncture or incinerate. Store at room temperature (59-86°F). Avoid direct exposure to sunlight.

  • DO NOT USE

    Do not use if tamper-evident seal is missing or torn from cap.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    Nasal and Sinus Health, Inc.
    16 Spring Hill Court
    Bluffton, SC 29910

    You may report any adverse effects to this address.

  • INGREDIENTS

    Active Ingredient: Seawater 80%

    Inactive Ingredient: Purified water 20% Sterilized solution is 2.6% NaCl (sea salt)

  • PRINCIPAL DISPLAY PANEL - 125 mL Canister Label

    ALL NATURAL SEAWATER
    SOLUTION
    HYPERTONIC NASAL SPRAY

    Breathe
    the Sea    ™

    The Every Day Nasal Spray™
    Preservative Free

    Use 2 – 4 times per day to:

    • Help Dry Congestion
      Due to Colds & Allergies
    • Breathe Easier
    • Soothe and Moisturize
    • Flush out Allergens & Irritants
    • Prewash Nasal Passages

    4.22 fl. oz. (125 mL)

    Principal Display Panel - 125 mL Canister Label
  • INGREDIENTS AND APPEARANCE
    BREATHE THE SEA   ALL-NATURAL SEAWATER
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52429-124
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride2600 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52429-124-01125 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other03/01/2012
    Labeler - Nasal and Sinus Health, Inc. (968415740)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nasal and Sinus Health, Inc.968415740RELABEL
    Establishment
    NameAddressID/FEIBusiness Operations
    Gerolymatos International423075886MANUFACTURE
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