BREATHE THE SEA ALL-NATURAL SEAWATER- sodium chloride spray

Breathe the Sea by

Drug Labeling and Warnings

Breathe the Sea by is a Otc medication manufactured, distributed, or labeled by Nasal and Sinus Health, Inc., Gerolymatos International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

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

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

SPL UNCLASSIFIED SECTION

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:

• 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)

INGREDIENTS AND APPEARANCE

BREATHE THE SEA   ALL-NATURAL SEAWATER
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52429-124
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37)	Sodium Chloride	2600 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52429-124-01	125 mL in 1 CANISTER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		03/01/2012

Labeler - Nasal and Sinus Health, Inc. (968415740)

Establishment
Name	Address	ID/FEI	Business Operations
Nasal and Sinus Health, Inc.		968415740	RELABEL

Establishment
Name	Address	ID/FEI	Business Operations
Gerolymatos International		423075886	MANUFACTURE