Label: SALINE NASAL 3OZ- sodium chloride spray
- NDC Code(s): 23558-6895-1
- Packager: Lee Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 15, 2013
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- Active ingredient
Sodium Chloride, 0.65%Close
For dry nasal membranesClose
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.
- 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, WaterClose
- INGREDIENTS AND APPEARANCE
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)