SALINE NASAL 1.5OZ- sodium chloride 0.65% spray 
Velocity Pharma 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%

Purpose

Moisturizer

Uses

For dry nasal membranes

Warnings

Do not use if seal is broken or missing.

Keep out of reach of children. The use of this dispenser by more than one person may spread infection.

Directions

Inactive ingredients

Benzalkonium chloride, Disodium phosphate, Phenylcarbinol, Monosodium phosphate, Water

Saline

SALINE NASAL  1.5OZ
sodium chloride 0.65% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76168-602
Route of AdministrationNASAL
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
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76168-602-1544 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/19/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/19/2019
Labeler - Velocity Pharma LLC (962198409)

Revised: 11/2019
Document Id: 97b51448-81d7-5817-e053-2995a90af43f
Set id: 06d66a1c-18ea-456b-a400-9666d374a615
Version: 2
Effective Time: 20191119
 
Velocity Pharma LLC