Derpixa by Scite Pharma, LLC DERPIXA-

Derpixa by

Drug Labeling and Warnings

Derpixa by is a Other medication manufactured, distributed, or labeled by Scite Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only

For topical use only

Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner.

Description

Derpixa is an occlusive, non-resorbable, self-drying and transparent gel.

When used as directed Derpixa dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion.

Derpixa helps to promote a moist healing environment.

This moist wound healing environment promotes faster re-epithelialization1and reduces the skin's acute inflammatory response.

Derpixa is suitable for large surface areas and contoured skin like head, face, hand and foot, as well as joints and hairy areas without the need for shaving.

1 Losi P et al. J Mater Sci Mater Med.2012;23(9):2235–43

Indication for use

Derpixa is intended to be used under the direction of healthcare practitioners in the management of cutaneous reactions.

Derpixa is indicated for use on all types of wounds, toxic and compromised skin including:

• Cutaneous reactions
• Pruritic, itchy skin
• Xerotic, dry skin
• Desquamation
• Fissures of skin and nail folds
• Blisters
• Medical Adhesive-Related Skin Injuries (MARSI)
• Erythema
• Infusion reactions
• Rashes, including: Maculopapular rash, hand-foot syndrome, GVHD, acneiform reaction, peri – and appendageal (hair follicles, sweat glands)

Derpixa is indicated for the relief of dry, itching, flaking, peeling and irritated skin, as well as the symptomatic relief of pain, redness and heat sensation.

Derpixa may be directly applied to dry skin, open wounds and compromised or desquamating skin surfaces, including cutaneous rashes.

Derpixa gel is bacteriostatic and inert.

It contains no alcohols, parabens or fragrances.

Derpixa can be used with or without a secondary protective dressing.

Derpixa is suitable for children and people with sensitive skin.

Derpixa is intended for single patient use.

Directions for use

Ensure that the affected superficial area is clean and dry.

Apply a very thin layer of Derpixa directly to the affected area and allow the gel to dry.

When applied correctly to exposed areas, Derpixa should be dry in 5–6 minutes.

If it takes longer to dry you have probably applied too much.

Gently remove the excess with a clean tissue or gauze and allow the drying process to continue.

Once dry, Derpixa may be covered by sunscreen, cosmetics and clothing.

Derpixa should be applied at least twice daily to affected areas, as needed or as advised by your physician.

For best results Derpixa should be maintained in continuous contact with the skin (24 hours a day/7 days a week).

How much Derpixa do I need?

Derpixa gel is an advanced formulation that requires substantially less product per application than typical creams or gels.

Derpixa 1 oz (28.5 g) is enough to treat an area of 6 × 12 inch (15 × 30 cm) twice per day for 30 days.

Warning

• For external use only.
• Derpixa should not be placed in contact with the eyes.
• Derpixa should not be applied over topical medications unless advised by your physician.
• Derpixa may stain clothing if not completely dry. If staining occurs, dry cleaning should be able to remove it without damaging the fabric.
• For correct storage please reclose the tube tightly with the cap.
• If irritation occurs, discontinue use and consult your physician.
• Keep out of the reach of children.
• Do not use after the expiration (EXP) date printed on the tube. The expiration (EXP) date does not change once the tube has been opened.
• Do not use if the tube is damaged.

Contraindications

Do not administer to patients with known hypersensitivity to the ingredients of this product.

STERILE UNTIL OPENED

Ingredients: Dimethylpolysiloxane, dihydroxysiloxane and alkylmethylsiloxane.

How supplied

Derpixa 1 oz (28.5 g) tube

SPL UNCLASSIFIED SECTION

Product identification code: 79043-150-28

SPL UNCLASSIFIED SECTION

Stratpharma AG
Aeschenvorstadt 57
CH-4051 Basel
Switzerland

Distributed by
Allegis Pharmaceuticals
Canton, MS 39046, USA

Date of preparation of this
information: 10/2020

Stratpharma
Switzerland

scite
PHARMA

Questions:
1-866-633-9033

CE

DP000USENPI01-1020

PRINCIPAL DISPLAY PANEL - 28.5 g Tube Box

79043-150-28

Rx Only
For topical use only

ADVANCED FORMULATION
Derpixa
for cutaneous reactions

gel
1 oz
28.5 g

INGREDIENTS AND APPEARANCE

DERPIXA 
dressing, wound, occlusive

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:79043-150

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:79043-150-28	1 in 1 BOX
1		28.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Exempt device	NAD	12/15/2020

Labeler - Scite Pharma, LLC (117555106)