NASALASALT  ALL-NATURAL SEAWATER- sodium chloride spray 
Nasal and Sinus Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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NASAL•ASALT™
ALL NATURAL SEAWATER SOLUTION
HYPERTONIC SALINE
MOISTURIZING
NASAL SPRAY

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.

INGREDIENTS

Active Ingredient: Seawater 80%

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

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

FOR COMFORT, HYGIENE AND
NASAL & SINUS HEALTH

The Every Day Nasal Spray™

Preservative Free

3.38 FL OZ (100 mL)

Hypertonic Saline Nasal Spray

Principal Display Panel - 100 mL Canister Carton
NASALASALT   ALL-NATURAL SEAWATER
sodium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52429-123
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:52429-123-011 in 1 BOX
1100 mL in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/01/2011
Labeler - Nasal and Sinus Health, Inc. (968415740)
Establishment
NameAddressID/FEIBusiness Operations
Nasal and Sinus Health, Inc.968415740RELABEL
Establishment
NameAddressID/FEIBusiness Operations
Gerolymatos International423075886MANUFACTURE

Revised: 9/2011
Document Id: 01df705a-5399-4014-a292-b3e922ba3dee
Set id: 3f1a03ce-00a9-4491-961d-4acb4a33af8e
Version: 1
Effective Time: 20110926
 
Nasal and Sinus Health, Inc.