SALINE NASAL- sodium chloride spray 
Lee Pharmaceuticals

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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Drug Facts

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

image of label

SALINE NASAL 
sodium chloride 0.65% spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:23558-0569
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:23558-0569-0 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 07/01/2013
Labeler - Lee Pharmaceuticals (056425432)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
Name Address ID/FEI Business Operations
Lee Pharmaceuticals 056425432 manufacture(23558-0569)

Revised: 9/2012
Document Id: 094fe364-ed6c-426e-af21-f6df02323d4d
Set id: 38a8b3e9-b761-4f92-815b-0070ab880fdb
Version: 1
Effective Time: 20120912
 
Lee Pharmaceuticals