NASALASALT- sodium chloride spray

NasalAsalt by

Drug Labeling and Warnings

NasalAsalt 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]

USES

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.

WARNINGS

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.

Keep out of reach of children.

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.

ACTIVE INGREDIENT

INGREDIENTS

Active Ingredient: Seawater 80%

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

SPL UNCLASSIFIED SECTION

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

NASALASALT™

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

INGREDIENTS AND APPEARANCE

NASALASALT   ALL-NATURAL SEAWATER
sodium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52429-123
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: 52429-123-01	1 in 1 BOX
1		100 mL in 1 CANISTER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/01/2011

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