DERPIXA- dressing, wound, occlusive    
Scite Pharma, LLC

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ADVANCED FORMULATION
Derpixa
for cutaneous reactions

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:

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

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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

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

Product identification code: 79043-150-28

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Consult instructions for use

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Use by date

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Batch code

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Sterilized using irradiation

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Do not use if the tube is damaged

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Upper limit of temperature

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

PRINCIPAL DISPLAY PANEL - 28.5 g Tube Box
DERPIXA 
dressing, wound, occlusive
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:79043-150
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:79043-150-281 in 1 BOX
128.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Exempt deviceNAD12/15/2020
Labeler - Scite Pharma, LLC (117555106)

Revised: 1/2021
Document Id: 314b6a04-bce3-490b-916e-019eb9a181ab
Set id: ddaefc3b-87f4-4b84-af63-11553ff6adf2
Version: 1
Effective Time: 20210122
 
Scite Pharma, LLC