Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)
Rebel Distributors Corp
SODIUM CHLORIDE
SODIUM CHLORIDE 6.5 mg in 1 mL
NASAL
OTC DRUG
For dry nasal membranes squeeze twice in each nostril as needed. Upright delivers a spray; Horizontally a stream; Upside down a drop.
OTC monograph final
SALINE MIST- SALINE MIST SPRAY REBEL DISTRIBUTORS CORP _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._ ---------- SALINE MIST DRUG FACTS ACTIVE INGREDIENT Sodium Chloride 0.65% KEEP OUT OF REACH OF CHILDREN US ES For dry nasal membranes squeeze twice in each nostril as needed. Upright delivers a spray; Horizontally a stream; Upside down a drop. WARNINGS The use of this dispenser by more than one person may spread infection. DIRECTIONS For dry nasal membranes squeeze twice in each nostril as needed. INACTIVE INGREDIENTS Purified Water, sodium chloride 0.65%, Disodium Phosphate, Phenylcarbinol, Monosodium Phosphate, Benzalkonium Chloride PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Rebel Distributors Corp SALINE MIST saline mist spray PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:216 9 5-353(NDC:458 0 2-357) 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 WATER (UNII: 0 59 QF0 KO0 R) SO DIUM PHO SPHATE, DIBASIC, DIHYDRATE (UNII: 9 4255I6 E2T) BENZYL ALCO HO L (UNII: LKG8 49 4WBH) SO DIUM PHO SPHATE, MO NO BASIC ANHYDRO US (UNII: KH7I0 4HPUU) BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:216 9 5-353-45 45 mL in 1 BOTTLE 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 0 4/24/20 0 9 LABELER - Rebel Distributors Corp (118802834) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Rebel Distributo rs Co rp 118 8 0 28 34 RELABEL, REPACK Revised: 2/2011 Lestu allt skjalið