Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Lee Pharmaceuticals
SODIUM CHLORIDE
SODIUM CHLORIDE 6.5 mg in 1 mL
NASAL
OTC DRUG
Moisturizer For dry nasal membranes
OTC monograph final
SALINE NASAL 3OZ- SODIUM CHLORIDE 0.65% 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._ ---------- _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_ 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 Lee Pharmaceuticals SALINE NASAL 3OZ sodium chloride 0.65% spray PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:23558 -6 8 9 5 ROUTE OF ADMINISTRATION NASAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH SO DIUM CHLO RIDE (UNII: 451W47IQ8 X) (CHLORIDE ION - UNII:Q32ZN48 6 9 8 ) SODIUM CHLORIDE 6 .5 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) SO DIUM PHO SPHATE, DIBASIC ANHYDRO US (UNII: 22ADO53M6 F) BENZYL ALCO HO L (UNII: LKG8 49 4WBH) SO DIUM PHO SPHATE, MO NO BASIC, ANHYDRO US (UNII: KH7I0 4HPUU) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:23558 -6 8 9 5-1 8 8 mL in 1 BOTTLE, SPRAY MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph final pa rt349 10 /0 1/20 13 LABELER - Lee Pharmaceuticals (056425432) REGISTRANT - Lee Pharmaceuticals (056425432) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Lee Pharmaceuticals 0 56 425432 ma nufa c ture (23558 -6 8 9 5) Revised: 11/2013 Přečtěte si celý dokument