Nasalasalt
FDA Label NDC 52429-123

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nasal And Sinus Health, Inc. for the product Nasalasalt (NDC 52429-123). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, directions, otc - when using, otc - keep out of reach of children, otc - do not use, precautions, inactive ingredient, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Purpose

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.

Otc - When Using

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Do Not Use

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.

Inactive Ingredient

INGREDIENTS

Active Ingredient: Seawater 80%

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

Other

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)

      Principal Display Panel (100 mL Canister Carton)

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