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Neosalus Cream

Last reviewed on RxList: 4/12/2016
Drug Description

NEOSALUS CREAM
Hydrating Topical Cream

For Topical Dermatological Use Only

Prescription Medical Device
Caution: Federal Law restricts this device to sale by, or on the order of a licensed healthcare practitioner.

DESCRIPTION

NEOSALUS CREAM is a fragrance-free, non-comedogenic water soluble dressing formulated for the management of various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.

Ingredients

Carbomer, dimethicone, ethylparaben, glycerin, methylparaben, phenoxyethanol, polysorbate 20, povidone, propylene glycol, propylparaben, purified water, sodium hydroxide, stearic acid, trolamine.

Indications & Dosage

INDICATIONS

NEOSALUS FOAM is indicated for management and relief of irritation experienced with various types of dermatoses, including atopic dermatitis and allergic contact dermatitis.

DOSAGE AND ADMINISTRATION

Directions For Use

Apply to affected area three times a day unless otherwise directed by a prescribing healthcare practitioner. NEOSALUS FOAM should be rubbed gently into the skin until it is completely absorbed.

Follow these important directions to ensure proper foaming and maximum delivery of product:

  • Shake canister vigorously before each use.
  • Turn upside down (nozzle down) to dispense.
  • Depress ridged portion of dispenser, as illustrated at right.

Depress ridged portion of dispenser - Illustration

HOW SUPPLIED

NEOSALUS FOAM is supplied in a 200 gram aerosolized canister bearing the NDC Number 23710-000-02, a 70 gram aerosolized canister bearing the NDC Number 23710-000-70, and a 10 gram aerosolized canister bearing the NDC Number 23710-000-01.

Store at controlled room temperature 15° to 25°C (59° to 77°F).

Contains flammable materials. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose to temperatures over 120°F (48°C) even when empty

Manufactured for : Quinnova Pharmaceuticals LLC., Jamison, PA 18929 (877) 660-6263. Revised: Jan 2013

Side Effects & Drug Interactions

SIDE EFFECTS

No information provided.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

WARNINGS

No information provided.

PRECAUTIONS

NEOSALUS FOAM is to be used only as directed by a healthcare practitioner. It should not be used to treat any condition other than that for which it is prescribed. For external use only. Avoid contact with the eyes, lips, and other mucous membranes. Exposure of the eye to NEOSALUS FOAM may result in reactions such as stinging and ocular irritation.

If a reaction to NEOSALUS FOAM suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued and the prescribing healthcare practitioner consulted. This product provides no sunscreen protection. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.

Certain temporary symptoms such as erythema, dryness, scaling, burning or pruritus may be experienced. These are most likely to occur during the first two to four weeks and will usually lessen with continued use of the medication. Depending upon the severity of the reaction patients should be instructed to reduce the frequency of application or discontinue use and to contact their prescribing healthcare practitioner.

KEEP THIS AND OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

Known hypersensitivity to any of the NEOSALUS FOAM ingredients.

Clinical Pharmacology
Medication Guide

PATIENT INFORMATION

Directions For Use

Apply to affected area three times a day unless otherwise directed by a prescribing healthcare practitioner. NEOSALUS FOAM should be rubbed gently into the skin until it is completely absorbed.

Follow these important directions to ensure proper foaming and maximum delivery of product:

  • Shake canister vigorously before each use.
  • Turn upside down (nozzle down) to dispense.
  • Depress ridged portion of dispenser, as illustrated at right.

Depress ridged portion of dispenser - Illustration

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Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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