FDA Label for Nasalasalt All-natural Seawater
View Indications, Usage & Precautions
Nasalasalt All-natural Seawater Product Label
The following document was submitted to the FDA by the labeler of this product Nasal And Sinus Health, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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 - To Soothe and Moisturize
- To Flush Out Allergens
and Irritants
FOR COMFORT, HYGIENE AND
NASAL & SINUS HEALTH
The Every Day Nasal Spray™
Preservative Free
3.38 FL OZ (100 mL)
Hypertonic Saline Nasal Spray
* Please review the disclaimer below.