NASAL SALINE- sodium chloride liquid

NASAL by

Drug Labeling and Warnings

NASAL by is a Otc medication manufactured, distributed, or labeled by GRAXCELL PHARMACEUTICAL, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Sodium Chloride 0.65%

Purpose

Helps to moisturize dry and irritated nasal passage.

Ingredients

Asolution in purified water (USP), made isotonic with sodium phosphate diabasic and sodium phosphate monobasic, with benzyl alcohol and benzalkonium chloride  as preservaitives.

Use

For dry nasal membranes squeeze twice in each nostril as needed.

Directions

upright delivers as a apray, horizontally for a stream, upside down as a drop.

Warnings

Use of this container by more than one person may spread infection.

If pregnant or breast feeding,

as a health care professional before use.

Keep out of reach of chlidren.

In case of accidential ingestion, get medical help or contac a Poison Control Center right away.

Saline Nasal Spray product label

NDC 70795-XXXX-X

GRAXCELL PHARMACEUTICAL, LLC

SALINE NASAL SPRAY

Compare to ingregients in Ocean® Saline Nasal Spray

Ideal for Seasonal Allergies

Helps to moisturize dry and irritated nasal passages from conditions like allergies, cold, flu, sinusitis and rhinitis

• Safe for Frequent, Daily Nasal Care
• Natural, Non-Medicated Relief
• 1.5 FL OZ (44mL) Bottle

TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF SAFETY SEAL OVER THE CAP IS BROKEN OR MISSING.

Manufactured For/Distributed by: Graxcell Pharmaceuticals
130 Knickerbocker Ave Bohemia, NY 11716

*This product is not manufactured or distributed by Valaent Consumer Products, distributers of Occean Saline Nasal Spray

Lot:

EXP:

INGREDIENTS AND APPEARANCE

NASAL  SALINE
sodium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70795-8014
Route of Administration	NASAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70795-8014-4	44 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	07/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2017

Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Registrant - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Establishment
Name	Address	ID/FEI	Business Operations
GRAXCELL PHARMACEUTICAL, LLC		056556923	relabel(70795-8014)