Aladerm Plus

Manufacturer
Allegis Pharmaceuticals, LLC
Effective date
2023-07-17
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:50:51

Label at a glance#

ProductAladerm Plus
Label structure10 sections

Dosage and administration

Apply a small amount of Aladerm Plus™ Rx Skin 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).

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only
28595-282-02

DESCRIPTION

DESCRIPTION SECTION

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.

INDICATIONS FOR USE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS SECTION

Aladerm Plus™ Rx Skin Emulsion is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

PRECAUTIONS

PRECAUTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Apply a small amount of Aladerm Plus™ Rx Skin 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

SPL UNCLASSIFIED SECTION

Deionized water, copolymer, vegetable oils from African palms, lidocaine HCl (less than 1%), and silver nanoparticles (as a preservative).

HOW SUPPLIED

HOW SUPPLIED SECTION

Aladerm Plus™ Rx Skin Emulsion is available in a 60 ml bottle.

SPL UNCLASSIFIED SECTION

PRESCRIPTION MEDICAL DEVICE:
FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

STORAGE AND HANDLING SECTION

SHAKE WELL BEFORE USING

STORE AT ROOM TEMPERATURE

SPL UNCLASSIFIED SECTION

Distributed by:
Allegis Pharmaceuticals, LLC
Canton, MS 39046

QUESTIONS: 1-866-633-9033

PRINCIPAL DISPLAY PANEL - 60 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

28595-282-02

Rx Only

Aladerm™
Plus

PATENT PENDING
An Allegis Pharmaceuticals Product

CAUTION: FEDERAL LAW RESTRICTS
THIS DEVICE TO SALE BY OR ON THE
ORDER OF A PHYSICIAN

STORE AT ROOM TEMPERATURE
SHAKE WELL BEFORE USE

Distributed by:

ALLEGIS PHARMACEUTICALS

Canton, MS 39046
1-866-633-9033 ∙ www.allegispharma.com

60ml (2oz)

PRINCIPAL DISPLAY PANEL - 60 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 60 ml Bottle Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
328595282022Aladerm Plus60 mL in 1 BOTTLE, SPRAYEMULSION602

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Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.