Your browser does not support JavaScript! SALINE NASAL (SODIUM CHLORIDE 0.65%) SPRAY [LEE PHARMACEUTICALS]
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RxNorm Names

SALINE NASAL (sodium chloride 0.65%) spray
[Lee Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • Squeeze twice in each nostril as needed
  • Upright delivers a spray, horizontally a stream, upside down a drop

Inactive ingredients

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

image of label

SALINE NASAL 
sodium chloride 0.65% spray
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:23558-0569
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION and 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:23558-0569-044 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/01/2013
Labeler - Lee Pharmaceuticals (056425432)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432manufacture(23558-0569)

Revised: 9/2012
 
Lee Pharmaceuticals

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