ENTSOL- sodium chloride spray

ENTSOL by

Drug Labeling and Warnings

ENTSOL by is a Otc medication manufactured, distributed, or labeled by PharmaDerm, A division of Fougera Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

Sodium chloride (3%)

Purpose:

Moisturizer

INDICATIONS & USAGE

Uses:

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

WARNINGS

Warnings:

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

DOSAGE & ADMINISTRATION

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.

SPL UNCLASSIFIED SECTION

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.

KEEP OUT OF REACH OF CHILDREN

CARTON SEALED FOR YOUR PROTECTION.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ENTSOL 
sodium chloride spray

Product 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)