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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:23558-6895
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (CHLORIDE ION) SODIUM CHLORIDE6.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
SODIUM PHOSPHATE, DIBASIC ANHYDROUS 
BENZYL ALCOHOL 
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23558-6895-188 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34910/01/2013
Labeler - Lee Pharmaceuticals (056425432)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432manufacture(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