SALINE NASAL by PURINEPHARMA LLC SALINE NASAL spray

SALINE NASAL by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Sodium Chloride 0.65%

PURPOSE

For allergies, cold, flu, sinusitis, rhinitis and dry irritated nasal passages

INDICATIONS & USAGE

Indications: For relief of dry nasal passages caused by sinus, cold and allergy medications, nasal surgery and dry air. Also relieves congestion by thinning mucus.

WARNINGS

WARNING:
If pregnant or breast feeding, ask a health professional before use.

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

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.

DOSAGE & ADMINISTRATION

Directions: For children and adults, squeeze bottle twice in each nostril as often as needed or as directed by doctor. For infants, use drop application. Hold bottle upright for spray, horizontally for stream and upside down for drop.

INACTIVE INGREDIENT

INGREDIENTS:
Sodium phosphate dibasic and sodium phosphate monobasic, with benzyl alcohol and benzalkonium chloride as preservatives.

PRINCIPAL DISPLAY PANEL

Made in USA

Manufactured by Purinepharma LLC
Massena, NY 13662 U.S.A.
*This product is not manufactured or distributed by Valeant Consumer Products, distributors of Ocean Saline Nasal Spray

INGREDIENTS AND APPEARANCE

SALINE NASAL 
saline nasal spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58599-036
Route of Administration	ORAL, Type 0: Not a Combination Product

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
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58599-036-19	44 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	02/07/2015

Labeler - PURINEPHARMA LLC (019950491)

Registrant - PURINEPHARMA LLC (019950491)

Establishment
Name	Address	ID/FEI	Business Operations
PURINEPHARMA LLC		019950491	manufacture(58599-036)