FDA Label for Breathe The Sea All-natural Seawater
View Indications, Usage & Precautions
Breathe The Sea 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.
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.
Otc - Do Not Use
Do not use with children under 6 years of age except as directed by a physician.
Do not use if tamper-evident seal is missing or torn from cap.
Otc - When Using
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.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Inactive Ingredient
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)
* Please review the disclaimer below.
