SALINE NASAL 3OZ- 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

label

SALINE NASAL  3OZ
sodium chloride 0.65% spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:23558-6895
Route of Administration NASAL DEA Schedule     
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
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:23558-6895-1 88 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 10/01/2013
Labeler - Lee Pharmaceuticals (056425432)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
Name Address ID/FEI Business Operations
Lee Pharmaceuticals 056425432 manufacture(23558-6895)

Revised: 11/2013
Document Id: b7d106d2-d409-40f3-a138-8dd341c24bb6
Set id: 829f3d56-a9a9-406e-bd1b-ce1ac9fa3055
Version: 3
Effective Time: 20131115
 
Lee Pharmaceuticals