Penlen Spray Emulsion Dailymed
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Description
Penlen® Spray Emulsion is a water-based topical skin care emulsion that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis.
Penlen® Spray Emulsion contains natural extracts to moisturize the skin.
Indications & Usage
As a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis.
Penlen® Spray Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.
Contraindications
Penlen Spray Emulsion is contraindicated in persons with a known hypersensitivity to any of the components of the formulation
Precautions
Penlen® Spray Emulsion is for external use only.
Product should not be used prior to MRI Imaging, as it contains silver nanoparticles that can cause heating during these procedures.
Penlen® Spray Emulsion does not contain sunscreen.
If the condition does not improve within 10 days, consult a physician.
If clinical signs of infection are present, appropriate treatment should be initiated; use of Penlen® Spray Emulsion may be continued during anti-infective therapy.
Keep this and other similar products out of the reach of children.
Directions For Use
Spray a small amount of Penlen® Spray Emulsion in sufficient quantity to cover the affected skin area to be protected, and allow to dry. Reapply up to 4 times per day (or as needed).
Ingredients
De-ionized water, copolymer, sodium hyaluronate in vegetable oils from African palms and silver nanoparticles (as a preservative).
How Supplied
Penlen® Spray Emulsion is available in a 90 mL spray bottle.
PRESCRIPTION MEDICAL DEVICE: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN
Storage And Handling Section
STORE AT ROOM TEMPERATURE
SHAKE WELL BEFORE USING
Distributed in the U.S.A. by:
SI Pharmaceuticals LLCMadison, MS 39110
Manufactured by: Laboratorios Zepol S.A. Costa Rica
FDA approval: K141637
Container Label
Penlen® Spray Emulsion 90 mL (NDC 70063-100-01)For Topical Dermatological Use only.Rx Only
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