Label: ALADERM PLUS- emulsion
- NDC Code(s): 328595282022
- Packager: Allegis Pharmaceuticals, LLC
- Category: PRESCRIPTION MEDICAL DEVICE LABEL
- DEA Schedule: None
- Marketing Status: Premarket Notification
Drug Label Information
Updated July 17, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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DESCRIPTION
Aladerm Plus™ Rx Skin 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.
Aladerm Plus™ Rx Skin Emulsion contains natural extracts to moisturize the skin.
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INDICATIONS FOR USE
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. Aladerm Plus™ Rx Skin Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.
- CONTRAINDICATIONS
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PRECAUTIONS
Aladerm Plus™ Rx Skin 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.
Aladerm Plus™ Rx Skin 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 Aladerm Plus™
Rx Skin Emulsion may be continued during anti-infective therapy.
Keep this and other similar products out of the reach of children.
- DIRECTIONS FOR USE
- INGREDIENTS
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 60 ml Bottle Label
28595-282-02
Rx Only
Aladerm™
PlusPATENT PENDING
An Allegis Pharmaceuticals ProductCAUTION: FEDERAL LAW RESTRICTS
THIS DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIANSTORE AT ROOM TEMPERATURE
SHAKE WELL BEFORE USEDistributed by:
ALLEGIS PHARMACEUTICALS
Canton, MS 39046
1-866-633-9033 ∙ www.allegispharma.com60ml (2oz)
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INGREDIENTS AND APPEARANCE
ALADERM PLUS
dressing, wound, drug emulsionProduct Information Product Type PRESCRIPTION MEDICAL DEVICE Item Code (Source) GS1:328595282022 Route of Administration TOPICAL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 GS1:328595282022 60 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 03/01/2025 Labeler - Allegis Pharmaceuticals, LLC (792272861)