StrataMark by Marnel Pharmaceuticals, Inc. / Stratpharma AG STRATAMARK-

StrataMark by

Drug Labeling and Warnings

StrataMark 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

StrataMark is a rapidly drying, non-sticky, transparent gel formulation for the management of Striae Distensae (stretch marks).

When used as directed, StrataMark dries to form a thin, flexible and protective layer, that is gas permeable and water-proof which hydrates and protects stretch marks, allowing the skin to normalize the collagen synthesis cycle.

StrataMark is suitable for all areas of the skin, including exposed and sensitive areas, as well as large areas of the body (i.e. buttocks, abdomen, thighs, breasts and back).

INDICATIONS & USAGE

Indication for use

StrataMark is intended to be used under the direction of healthcare practitioners in the management of stretch marks.

StrataMark is indicated for the management of all types of stretch marks, particularly those covering a wide surface area, resulting from pregnancy, adolescent growth spurts, weight gain or loss, or bodybuilding.

StrataMark is indicated to soften and flatten stretch marks, reduce redness and discoloration associated with stretch marks as well as to relieve the itching and discomfort of stretch marks.

It contains no alcohols, parabens or fragrances.

StrataMark is suitable for pregnant women, breastfeeding mothers, children and people with sensitive skin.

StrataMark is intended for single patient use.

INDICATIONS & USAGE

Directions for use

On the first use of 1.75 oz (50g) tubes, remove the cap, then the protective seal and close with the cap after use.

Ensure that the skin is clean and dry.

Apply a very thin layer of StrataMark to the relevant areas with the fingertips and distribute evenly to form a very thin layer and allow the gel to dry.

When applied, StrataMark 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, StrataMark can be covered with undergarments, sunscreens or cosmetics.

StrataMark should be applied once per day or as advised by your physician.

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

INFORMATION FOR PATIENTS

How much StrataMark do I need?

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

StrataMark 1.75 oz (50g) is enough to treat an area of 12x12 inch (30x30cm) for 30 days.

WARNINGS

Warning

• For external use only.
• StrataMark should not be applied to third degree burns or to open wounds.
• StrataMark should not be placed in contact with eyes.
• StrataMark should not be applied over other skin treatments without the advice of your physician.
• StrataMark 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: Dimethylpolysiloxane, dihydroxysiloxane and alkylmethylsiloxane.

HOW SUPPLIED

How supplied:

StrataMark 1.75 oz (50g) tube

SPL UNCLASSIFIED SECTION

Product identification code:

73661-423-50

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

STRATAMARK 
dressing, wound, occlusive

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:73661-423

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:73661-423-50	1 in 1 BOX
1		50 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	07/11/2020

Labeler - Marnel Pharmaceuticals, Inc. (080161449)

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