ENTSOL

Dosage form: spray
Ingredients: SODIUM CHLORIDE 30mg in 1mL
Labeler: PharmaDerm, A division of Fougera Pharmaceuticals Inc.
NDC Code: 10337-311

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.

ENTSOL® SPRAY
Buffered Hypertonic Saline Nasal Spray

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:

Sodium chloride (3%)

Purpose:

Moisturizer

Uses:

  • wash away allergens, dust, dirt & pollens
  • increse ciliary flow
  • improve breathing
  • clear congestion
  • help reduce nasal swelling

Warnings:

  • Use at room temperature only
  • Do not use if nose is completely blocked
  • Avoid oral consumption

Directions:

  • Important - Keep container in vertical position during use. Insert nozzle in one nostril.
  • Lightly press down on applicator with finger.
  • Repeat the same in other nostril.
  • Spray 2 to 6 times daily or as instructed by a physician.
  • Wipe nozzle clean after each use.

Other information:

  • Contents under air pressure. Do not dent or puncture container.
  • Keep container out of direct sunlight.
  • Store at room temperature, 15° - 30°C (59° and 86°F).

Inactive Ingredients

Purified Water, Sodium Phosphate - Dibasic, Potassium Phosphate - Monobasic.

CARTON SEALED FOR YOUR PROTECTION.

Manufactured for

PharmaDerm®

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747 USA

www.pharmaderm.com

Manufactured by:

Laboratoires Chemineau

Vouvray, France

CE

0459

IC 142B R11/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

NDC 10337-311-10

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

NDC 10337-311-10

ENTSOL 
sodium chloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10337-311
Route of AdministrationNASALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM PHOSPHATE, DIBASIC 
POTASSIUM PHOSPHATE, MONOBASIC 
Packaging
#Item CodePackage Description
1NDC:10337-311-101 BOTTLE, SPRAY in 1 CARTON
1100 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/01/2000
Labeler - PharmaDerm, A division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 04/2012
 
PharmaDerm, A division of Fougera Pharmaceuticals Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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