StrataTriz by Marnel Pharmaceuticals, Inc. / Stratpharma AG STRATATRIZ-

StrataTriz by

Drug Labeling and Warnings

StrataTriz by is a Other medication manufactured, distributed, or labeled by Marnel Pharmaceuticals, Inc., Stratpharma AG. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS AND PRECAUTIONS

Rx Only

For topical use only

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

DESCRIPTION

[EN] Description

StrataTriz is a transparent gel formulation for the management of scars, both old and new.

When used as directed StrataTriz dries to form a protective layer that is gas permeable and waterproof which hydrates and protects scars from chemical and microbial invasion, allowing scars to normalize the collagen synthesis cycles, producing a normal mature scar.

StrataTriz is suitable for all areas of the skin, including exposed areas like the face and neck as well as joints and hairy areas without the need for shaving.

INDICATIONS & USAGE

Indication for use

StrataTriz is intended to be used under the direction of healthcare practitioners in the management of scars.

StrataTriz is indicated for the use on all types of scars including those resulting from:

• general and cosmetic surgery
• trauma
• chronic wounds
• burns
• bites
• acne, and other diseases of the skin.

StrataTriz is indicated to soften and flatten scars, relieve the itching and discomfort as well as to reduce redness and discoloration associated with scars.

StrataTriz is used for the topical management of keloids and hypertrophic scars.

It contains no alcohols, parabens or fragrances.

StrataTriz is suitable for children or people with sensitive skin.

StrataTriz is suitable to use on infants, during pregnancy and whilst breast-feeding.

StrataTriz is intended for single patient use.

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

INDICATIONS & USAGE

Directions for use

Ensure that the scar is clean and dry.

Apply a very thin layer of StrataTriz to the scar and allow to dry.

When applied correctly, StrataTriz should be dry in 3-4 minutes.

If it takes longer to dry you have probably applied too much.  Gently remove the excess with a tissue and allow the drying process to continue.

Once dry, StrataTriz can be covered with sunscreen, cosmetics, pressure garments or casts.

StrataTriz should be applied once daily, or twice daily to exposed areas or as advised by your physician.

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

INFORMATION FOR PATIENTS

How much StrataTriz do I need?

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

StrataTriz 0.7 oz (20g) is enough to treat an area of 5x5 inch (12x12cm) twice per day for 30 days.

WARNINGS

Warning

• For external use only.
• StrataTriz should not be applied on third degree burns or to open wounds.
• StrataTriz should not be placed in contact with mucous membranes or the eyes.
• StrataTriz should not be applied over topical medications unless advised by your physician.
• StrataTriz 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

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

SPL UNCLASSIFIED SECTION

Ingredients: Polydimethylsiloxane, hydroxysiloxane and alkyl siloxane resin.

How supplied:

StrataTriz 0.7 oz (20g) tube

Product identification code:

73661-424-20

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STRATATRIZ 
dressing, wound, occlusive

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:73661-424

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:73661-424-20	1 in 1 BOX
1		20 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	07/15/2020

Labeler - Marnel Pharmaceuticals, Inc. (080161449)

Establishment
Name	Address	ID/FEI	Business Operations
Stratpharma AG		483232695	manufacture