Label: SALINE NASAL spray
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Contains inactivated NDC Code(s)
NDC Code(s): 58599-036-19 - Packager: PURINEPHARMA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 7, 2015
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SALINE NASAL
saline nasal sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58599-036 Route of Administration ORAL, Type 0: Not a Combination Product 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 SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU) BENZYL ALCOHOL (UNII: LKG8494WBH) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58599-036-19 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 02/07/2015 Labeler - PURINEPHARMA LLC (019950491) Registrant - PURINEPHARMA LLC (019950491) Establishment Name Address ID/FEI Business Operations PURINEPHARMA LLC 019950491 manufacture(58599-036)