Label: PENLEN SPRAY EMULSION-
- NHRIC Code(s): 70063-100-01
- Packager: SI Pharmaceuticals LLC
- Category: PRESCRIPTION MEDICAL DEVICE LABEL
- DEA Schedule: None
- Marketing Status: Premarket Notification
Updated December 4, 2018
If you are a consumer or patient please visit this version.
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.
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
- HOW SUPPLIED
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- Container Label
INGREDIENTS AND APPEARANCE
PENLEN SPRAY EMULSION
dressing, wound, drug
Product Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) NHRIC:70063-100 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:70063-100-01 1 in 1 CARTON 1 90 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date premarket notification K141637 12/04/2018 Labeler - SI Pharmaceuticals LLC (079881205)