Label: SODIUM CHLORIDE-
SODIUM CHLORIDE-
SODIUM CHLORIDE-
-
NHRIC Code(s):
0487-9301-33,
0487-9301-03,
0487-9301-02,
0487-9302-01, view more0487-9315-30
- Packager: Nephron Pharmaceuticals Corporation
- Category: MEDICAL DEVICE
- DEA Schedule: None
- Marketing Status: Exempt device
Drug Label Information
Updated January 30, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
-
Sodium Chloride Inhalation Solution, USP 0.9% 3 mL
NDC 0487-9301-33
Sodium Chloride
Inhalation Solution, USP 0.9%Sterile, non-pyrogenic, preservative-free
single-use vials for respiratory therapy.No bacteriostatic agent or other
preservative added.MADE
IN THE
USAFor Respiratory Therapy
Not for parenteral administration.nephron
pharmaceuticals
corporation
Orlando, FL 3281130 × 3 mL Sterile Unit-Dose Vials, each in a foil pouch.
INDICATIONS: This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.
This device is not intended for parenteral use or for preparations intended for parenteral use.
WARNING: Not for injection or in preparations to be used for injection.
DIRECTIONS FOR USE: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.
Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.
HOW SUPPLIED: Sodium Chloride Inhalation Solution, USP 0.9% is supplied in single-use plastic vials in the following configurations:
NDC 0487-9301-03 3 mL, 100 vials per carton
NDC 0487-9301-33 3 mL, 30 vials per carton / 1 vial per foil pouch
NDC 0487-9301-02 3 mL, 30 vials per carton / 1 vial per foil pouch / robot ready
NDC 0487-9302-01 5 mL, 100 vials per carton
NDC 0487-9315-30 15 mL, 30 vials per cartonInternal contents sterile. External surface of vial not sterile.
STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).
Rx Only
Please Recycle
IC 426
Rev. 09-23-14
-
Sodium Chloride Inhalation Solution, USP 0.9% 5 mL
NDC 0487-9302-01
Sodium Chloride
Inhalation Solution, USP 0.9%Sterile, non-pyrogenic, preservative-free
single-use vials for respiratory therapy.No bacteriostatic agent or other preservative
added.For Respiratory Therapy
Not for parenteral administration.100 × 5 mL Sterile Unit-Dose Vials
Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811INDICATIONS: This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.
This device is not intended for parenteral use or for preparations intended for parenteral use.
WARNING: Not for injection or in preparations to be used for injection.
DIRECTIONS FOR USE: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.
Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.
HOW SUPPLIED: Sodium Chloride Inhalation Solution, USP 0.9% is supplied in single-use plastic vials in the following configurations:
NDC 0487-9301-03 3 mL, 100 vials per carton
NDC 0487-9301-33 3 mL, 30 vials per carton / 1 vial per foil pouch
NDC 0487-9301-02 3 mL, 30 vials per carton / 1 vial per foil pouch / robot ready
NDC 0487-9302-01 5 mL, 100 vials per carton
NDC 0487-9315-30 15 mL, 30 vials per cartonInternal contents sterile. External surface of vial not sterile.
STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).
Rx Only
Please Recycle
IC 440
Rev. 09-23-14
-
Sodium Chloride Inhalation Solution, USP 0.9% 15 mL
NDC 0487-9315-30
Sodium Chloride
Inhalation Solution, USP 0.9%Sterile, non-pyrogenic, preservative-free single-use vials for
respiratory therapy.No bacteriostatic agent or other preservative added.
For Respiratory Therapy
Not for parenteral administration.30 × 15 mL Sterile Unit-Dose Vials
Manufactured By:
nephron
pharmaceuticals
corporation
Orlando, FL 32811MADE
IN THE
USAINDICATIONS: This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.
This device is not intended for parenteral use or for preparations intended for parenteral use.
WARNING: Not for injection or in preparations to be used for injection.
DIRECTIONS FOR USE: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.
Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.
HOW SUPPLIED: Sodium Chloride Inhalation Solution, USP 0.9% is supplied in single-use plastic vials in the following packaging configurations:
NDC 0487-9301-03 3 mL, 100 vials per carton
NDC 0487-9301-33 3 mL, 30 vials per carton / 1 vial per foil pouch
NDC 0487-9301-02 3 mL, 30 vials per carton / 1 vial per foil pouch / robot ready
NDC 0487-9302-01 5 mL, 100 vials per carton
NDC 0487-9315-30 15 mL, 30 vials per cartonSTORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).
Internal contents sterile. External surface of vial not sterile.
Rx OnlyIC 446
Rev. 08-27-14
-
INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
nebulizer (direct patient interface)Product Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:0487-9301 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:0487-9301-33 30 in 1 CARTON 1 1 in 1 POUCH 1 3 mL in 1 VIAL, SINGLE-USE 2 NHRIC:0487-9301-03 100 in 1 CARTON 2 3 mL in 1 VIAL, SINGLE-USE 3 NHRIC:0487-9301-02 1 in 1 BAG 3 1 in 1 POUCH 3 3 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EXEMPT DEVICE CAF 06/25/2012 SODIUM CHLORIDE
nebulizer (direct patient interface)Product Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:0487-9302 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:0487-9302-01 100 in 1 CARTON 1 5 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EXEMPT DEVICE CAF 06/25/2012 SODIUM CHLORIDE
nebulizer (direct patient interface)Product Information Product Type MEDICAL DEVICE Item Code (Source) NHRIC:0487-9315 Route of Administration RESPIRATORY (INHALATION) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Chloride (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) Sodium Chloride 9 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:0487-9315-30 30 in 1 CARTON 1 15 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date EXEMPT DEVICE CAF 02/09/2015 Labeler - Nephron Pharmaceuticals Corporation (783905201) Establishment Name Address ID/FEI Business Operations Nephron Pharmaceuticals Corporation 783905201 MANUFACTURE, ANALYSIS, PACK