StrataMark: Package Insert and Label Information

STRATAMARK-
Marnel Pharmaceuticals, Inc.

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 12×12 inch (30x30cm) for 30 days.

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:

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 description
(click image for full-size original)
image description
(click image for full-size original)

STRATAMARK
Product Information
Product Type Item Code (Source) NHRIC:73661-423
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE
DIMETHICONOL (2000 CST)
CAPRYLYL TRISILOXANE
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:73661-423-50 1 TUBE in 1 BOX contains a TUBE
1 50 g in 1 TUBE This package is contained within the BOX (73661-423-50)
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 Operations
Stratpharma AG 483232695 manufacture

Revised: 07/2020 Marnel Pharmaceuticals, Inc.

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.