BREATHE THE SEA  ALL-NATURAL SEAWATER- sodium chloride spray 
Nasal and Sinus Health, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Breathe the Sea™ All-Natural Seawater Solution
Hypertonic Nasal Spray

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 if tamper-evident seal is missing or torn from cap.

KEEP OUT OF REACH OF CHILDREN

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:

4.22 fl. oz. (125 mL)

Principal Display Panel - 125 mL Canister Label
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

Revised: 2/2012
Document Id: 42549b28-7afe-4f59-97fc-2dca2ff816bd
Set id: 7b890f22-8532-488c-be7e-6ac65bf7248c
Version: 2
Effective Time: 20120217
 
Nasal and Sinus Health, Inc.