SALINE NASAL- saline nasal spray 
PURINEPHARMA LLC

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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SALINE NASAL SPRAY

Active Ingredient: Sodium Chloride 0.65%

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

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.

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.

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.

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

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

44mL
SALINE NASAL 
saline nasal spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58599-036
Route of AdministrationORAL, Type 0: Not a Combination Product
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58599-036-1944 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/07/2015
Labeler - PURINEPHARMA LLC (019950491)
Registrant - PURINEPHARMA LLC (019950491)
Establishment
NameAddressID/FEIBusiness Operations
PURINEPHARMA LLC019950491manufacture(58599-036)

Revised: 2/2015
Document Id: f3470af4-c278-48a4-9de9-2d6d974ab2eb
Set id: f3470af4-c278-48a4-9de9-2d6d974ab2eb
Version: 1
Effective Time: 20150207
 
PURINEPHARMA LLC