Label: ENTSOL- sodium chloride spray
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Contains inactivated NDC Code(s)
NDC Code(s): 10337-311-10 - Packager: PharmaDerm, A division of Fougera Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 25, 2012
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- Official Label (Printer Friendly)
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DESCRIPTION
Recommended by leading ENTs, Allergists, and Pediatricians for fastacting, temporary relief...to enhance ciliary flow...as a pre-treatment for nasal steroid use. Reliable uniformity of dosage, buffered hypertonic saline nasal spray under pressure. Washes away allergens, dust, dirt and pollens.
Improves breathing. Clears congestion. Helps reduce nasal swelling. Helps relieve symptoms of sinusitis, allergies/ rhinitis, headaches, congestion, postnasal drip, and coughs due to postnasal drip. Effective treatment for preand post-surgical care. Pre-treatment for nasal steroid use.
Directions:
For best results, keep spray can in vertical position during use. Insert nozzle in one nostril. Lightly press down on applicator with finger to create spray.Repeat same procedure in other nostril. Spray 2 to 6 times daily or as instructed by a physician. Wipe nozzle clean after each use.
Ingredients:
Purified Water, Sodium Chloride, Sodium Phosphate - Dibasic, Potassium Phosphate - Monobasic.
Caution:
Contents under pressure. Do not dent or puncture can. Keep out of direct sunlight. Store and use at room temperature, between 15°- 30°C (59°-86°F). Please properly dispose of the container when the propellant is depleted. Note: It is not unusual that some liquid might remain in the container after all of the propellant is depleted. Use at room temperature only. Do not use if nose is completely blocked. Avoid oral consumption.
No CFCs - Environment Friendly
IL 133B R10/11
AN0795 0004
- Active Ingredient:
- Purpose:
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- Inactive Ingredients
- KEEP OUT OF REACH OF CHILDREN
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
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INGREDIENTS AND APPEARANCE
ENTSOL
sodium chloride sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10337-311 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10337-311-10 1 in 1 CARTON 1 100 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/01/2000 Labeler - PharmaDerm, A division of Fougera Pharmaceuticals Inc. (043838424)
