StrataGRT

Manufacturer
Marnel Pharmaceuticals, Inc. | Stratpharma AG
Effective date
2020-07-11
Label type
MEDICAL DEVICE
Version
2
Source
full-release
Hydrated at
2026-06-01 02:49:39

Label at a glance#

ProductStrataGRT
Label structure12 sections

Label contents#

Full prescribing information#

WARNINGS AND PRECAUTIONS 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 SECTION

[EN] Description

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

When used as directed, StrataGRT dries to form a protective layer that is gas permeable and waterproof which hydrates and protects chronic and hard to treat wounds.

StrataGRT helps to promote a moist healing environment.  This moist wound healing environment promotes faster re-epithelialization* and reduces the skin's acute inflammatory response.

StrataGRT is suitable for exposed areas like the face and neck as well as joints and hairy areas without the need for shaving.

INDICATIONS & USAGE SECTION

Indication for use

StrataGRT is intended to be used under the direction of healthcare practitioners in the management of chronic and hard to treat wounds.

StrataGRT is indicated for use on all types of chronic and acute wounds.

StrataGRT may be directly applied to fresh incisions and excisions, open wounds and compromised skin surfaces.

StrataGRT gel is bacteriostatic and inert.

StrataGRT contains no alcohols, parabens or fragrances.

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

StrataGRT is suitable for infants, children, people with sensitive skin, during pregnancy and while breastfeeding.

StrataGRT is intended for single patient use.

INDICATIONS & USAGE SECTION

Directions for use

On first use of 0.7 oz (20 g) tubes remove the cap, cut the nozzle tip of the tube and close with the cap after use.

Ensure that the affected superficial area is cleaned before each application.

Gently pat dry as much excess exudate or wound fluid from the area as possible prior to gel application.

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

On wounds not requiring a secondary dressing:

Apply a thin layer of StrataGRT to the affected area and allow the gel to dry.

When applied correctly to exposed areas, StrataGRT 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.

StrataGRT should be applied twice daily to exposed areas or as advised by your physician.

If StrataGRT has been removed by washing, it should be reapplied.

On wounds requiring a secondary dressing:

Apply a thin layer of StrataGRT then cover with secondary dressing.

Drying is not necessary.

StrataGRT should be reapplied when changing the dressing or checking the wound progress, or as advised by your physician.

INFORMATION FOR PATIENTS SECTION

How much StrataGRT do I need?

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

StrataGRT 0.7 oz (20g) is enough to treat an area of 5X5 inch (12X12 cm) twice per day for 30 days.

WARNINGS SECTION

Warning

  • For external use only.
  • StrataGRT should not be placed in contact with the eyes.
  • StrataGRT should not be applied over other skin treatment without the advice of your physician.
  • StrataGRT 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 SECTION

Contraindications

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

INFORMATION FOR PATIENTS SECTION

STERILE UNTIL OPENED

SPL UNCLASSIFIED SECTION

Ingredients:  Linear dimethylpolysiloxanes, octamethyltrisiloxane and siloxane resin.

HOW SUPPLIED SECTION

How supplied:

StrataGRT 0.7 oz (20g) tube

SPL UNCLASSIFIED SECTION

Product Identification code:

73661-422-20

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73661-422-20StrataGRT20 g in 1 TUBE202
73661-422-20StrataGRT1 in 1 BOX12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73661-422STRATAGRT () [MARNEL PHARMACEUTICALS, INC.]22 package rows20200712_732ad204-c969-40db-95c7-e5da5801f910.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73661-422-20GM - Gram73661-4224ccea03f-2bf0-401e-a18b-af77322db01812020-08-06

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
73661-42273661-422-20

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 · 131 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.