ENTSOL

PharmaDerm, A division of Fougera Pharmaceuticals Inc.

ENTSOL SPRAY Buffered Hypertonic Saline Nasal Spray

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient:
• Purpose:
• Inactive Ingredients
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
• PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

FULL PRESCRIBING INFORMATION

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

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