Derpixa

Manufacturer
Scite Pharma, LLC
Effective date
2023-07-17
Label type
MEDICAL DEVICE
Version
2
Source
full-release
Hydrated at
2026-06-01 02:52:09

Label at a glance#

ProductDerpixa
Label structure11 sections

Dosage and administration

On the first use of 1 oz (28.5 g) tubes remove the cap, then the protective seal and close with the cap after 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 rem...

Label contents#

Full prescribing information#

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

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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

SPL UNCLASSIFIED SECTION

Directions for useDirections for use

On the first use of 1 oz (28.5 g) tubes remove the cap, then the protective seal and close with the cap after 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

WARNINGS SECTION

  • 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

CONTRAINDICATIONS SECTION

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

STERILE UNTIL OPENED

SPL UNCLASSIFIED SECTION

Ingredients: Dimethylpolysiloxane, dihydroxysiloxane and alkylmethylsiloxane.

How supplied

HOW SUPPLIED SECTION

Derpixa 1 oz (28.5 g) tube

SPL UNCLASSIFIED SECTION

Product identification code: 79043-150-28

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

Consult instructions for use

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

Use by date

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

Batch code

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

Sterilized using irradiation

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

Do not use if the tube is damaged

SPL UNCLASSIFIED SECTIONSPL UNCLASSIFIED SECTION

Upper limit of temperature

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

79043-150-28

Rx Only
For topical use only

ADVANCED FORMULATION
Derpixa
for cutaneous reactions

gel
1 oz
28.5 g

PRINCIPAL DISPLAY PANEL - 28.5 g Tube Box
PRINCIPAL DISPLAY PANEL - 28.5 g Tube Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79043-150-28Derpixa28.5 g in 1 TUBE28.52
79043-150-28Derpixa1 in 1 BOX12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
79043-150-28GM - Gram79043-15069ca937f-3ff3-4c74-9934-55b0512e202512021-02-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79043-15079043-150-28

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 7 · 132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsName fallback
generic name: DIMETHICONE
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsName fallback
generic name: DIMETHICONE
Neoteric Diabetic Skin Care 1 oz.DIMETHICONERNA PHARMA LLC5a944486-9591-f583-e063-6394a90aa04b2026-09-03WarningsName fallback
generic name: DIMETHICONE
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsName fallback
generic name: DIMETHICONE
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsName fallback
generic name: DIMETHICONE
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsName fallback
generic name: DIMETHICONE
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsName fallback
generic name: DIMETHICONE
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsName fallback
generic name: DIMETHICONE
Mederma PMDIMETHICONEL Perrigo Company8c728904-28f4-4333-a9ea-20996fd1b0072026-08-21WarningsName fallback
generic name: DIMETHICONE
Claravie Skin Repair CreamDIMETHICONEGentell LLC596ae269-172e-aef5-e063-6394a90a4e2a2026-08-19WarningsName fallback
generic name: DIMETHICONE
Mederma Stretch Marks TherapyDIMETHICONEPMI Branded Pharmaceuticals, Inc.0f2918e3-9615-40e3-ab7e-6bfbe022e03c2026-07-16WarningsName fallback
generic name: DIMETHICONE
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsName fallback
generic name: DIMETHICONE
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsName fallback
generic name: DIMETHICONE
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsName fallback
generic name: DIMETHICONE
DIMETHICONE SKIN PROTECTANTDIMETHICONEVIVE HEALTH LLC5591a321-4831-1844-e063-6394a90a12d12026-07-01WarningsName fallback
generic name: DIMETHICONE
Comfort Shield BarrierDIMETHICONESage Products LLCcc08f571-84ae-4c2f-b09d-a83a8efc39f52026-06-23WarningsName fallback
generic name: DIMETHICONE
Neoteric Diabetic Skin Care 4 oz.DIMETHICONERNA PHARMA LLC536f4e79-201b-7100-e063-6394a90a4f822026-06-16WarningsName fallback
generic name: DIMETHICONE

Reported adverse events (FAERS/openFDA)#

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