STRATAMARK- dressing, wound, occlusive    
Marnel Pharmaceuticals, Inc.

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StrataMark

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

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).

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.

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).

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.

Warning

Contraindications:

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

Ingredients: Dimethylpolysiloxane, dihydroxysiloxane and alkylmethylsiloxane.

How supplied:

StrataMark 1.75 oz (50g) tube

Product identification code:

73661-423-50

image descriptionimage description

STRATAMARK 
dressing, wound, occlusive
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:73661-423
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:73661-423-501 in 1 BOX
150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceNAD07/11/2020
Labeler - Marnel Pharmaceuticals, Inc. (080161449)
Establishment
NameAddressID/FEIBusiness Operations
Stratpharma AG483232695manufacture

Revised: 7/2020
Document Id: 2fc05c22-628e-4dad-ad29-1404efe7ea5d
Set id: 274312bf-5db7-4512-accf-9bace6865171
Version: 1
Effective Time: 20200711
 
Marnel Pharmaceuticals, Inc.