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.
Rx Only
For topical use only
Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner.
[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.
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.
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.
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.
Warning
Contraindications
Do not administer to patients with known hypersensitivity to the ingredients of this product.
STERILE UNTIL OPENED
Ingredients: Linear dimethylpolysiloxanes, octamethyltrisiloxane and siloxane resin.
How supplied:
StrataGRT 0.7 oz (20g) tube
Product Identification code:
73661-422-20
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 73661-422-20 | StrataGRT | 20 g in 1 TUBE | 20 | 2 | ||
| 73661-422-20 | StrataGRT | 1 in 1 BOX | 1 | 2 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 73661-422-20 | GM - Gram | 73661-422 | 4ccea03f-2bf0-401e-a18b-af77322db018 | 1 | 2020-08-06 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 73661-422 | 73661-422-20 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DIMETHICONE | 92RU3N3Y1O | IACT |
| TRISILOXANE | 9G1ZW13R0G | IACT |
| TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) | 5041RX63GN | IACT |
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