Label: NASALASALT- 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 September 26, 2011

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  • USES

    NasalAsalt® may be used 2-4 times per day to help provide fast temporary relief from swelling and congestion.

    Use NasalAsalt® as a prewash to help clear mucous buildup prior to using other nasal sprays.

  • 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 best results, see package insert for the Vanderpool Technique™ for a more thorough nasal cleansing procedure or go to the NasalAsalt® web site for a video demonstration.

  • WARNINGS

    Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120° F. Recommended storage at room temperature 59-86°F. Avoid direct exposure to sunlight.

    Keep out of reach of children.

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

  • 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.

  • ACTIVE INGREDIENT

    INGREDIENTS

    Active Ingredient: Seawater 80%

    Inactive Ingredient: Purified Water 20% Sterilized solution equivalent to 2.6% NaCl (sea salt)

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Nasal and Sinus Health, Inc., 16 Spring Hill Court, Bluffton, SC 29910. You may report serious side effects to this address.

  • PRINCIPAL DISPLAY PANEL - 100 mL Canister Carton

    NASAL•ASALT™

    ALL NATURAL SEAWATER SOLUTION
    HYPERTONIC SALINE
    MOISTURIZING
    NASAL SPRAY

    Targets Nasal
    Dryness, Swelling
    and Congestion
    Caused by:

    COLDS
    ALLERGIES

    Additional Uses:
    AS A NASAL CLEANSE AND
    PREWASH SOLUTION

    • To Help Clear Mucous Buildup
      Prior to Using Other Nasal Sprays

    FOR COMFORT, HYGIENE AND
    NASAL & SINUS HEALTH

    • To Soothe and Moisturize
    • To Flush Out Allergens
      and Irritants

    The Every Day Nasal Spray™

    Preservative Free

    3.38 FL OZ (100 mL)

    Hypertonic Saline Nasal Spray

    Principal Display Panel - 100 mL Canister Carton
  • INGREDIENTS AND APPEARANCE
    NASALASALT   ALL-NATURAL SEAWATER
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52429-123
    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:52429-123-011 in 1 BOX
    1100 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/01/2011
    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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