What is StrataCTX?

StrataCTX is indicated for use on all types of wounds, toxic and compromised skin including: cutaneous reactions, pruritic, itchy skin, xerotic, dry skin, desquamation, fissures of skin and nail folds, blisters, Medical Adhesive-Related Skin Injuries (MARSI), erythema, infusion reactions, rashes, including: maculopapular rash, hand-foot syndrome, GVHD, acneiform reaction, peri – and appendageal (hair follicles, sweat glands). StrataCTX is intended to be used under the direction of healthcare practitioners in the management of cutaneous reactions. Federal Law restricts this device to sale by or on the order of a licensed healthcare practitioner.

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Film-forming, full contact, flexible wound dressing

StrataCTX is a flexible, full contact wound dressing that forms a thin film that ensures constant contact with the skin.

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Faster wound healing

StrataCTX promotes a moist healing environment leading to faster re-epithelialization.

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Symptomatic relief

StrataCTX provides symptomatic relief of dry, itching, flaking, peeling and irritated skin, pain, redness and heat sensation.

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Hydration

StrataCTX dries to form a protective layer that is gas permeable and waterproof which hydrates compromised skin areas and superficial wounds.

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Protection

StrataCTX is bacteriostatic, it protects the skin from irritants and microbial invasion while reducing the risk of contact dermatitis.

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Non-Reactive

StrataCTX is non-reactive, it has no measurable pH, contains no alcohol, parabens or fragrances, making it suitable for children, and people with sensitive skin.

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Secondary dressings

Once dry, StrataCTX does not inhibit secondary dressings or adhesives from sticking to the skin surface.

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Transparent

StrataCTX is transparent and is not absorbed through the skin. It is suitable for monitoring the skin condition without the need of having to remove a physical dressing or adhesive.

How does StrataCTX work?

When used as directed StrataCTX dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical irritants and microbial invasion. StrataCTX is a self-drying, non-sticky gel formulation that lightly bonds to the most superficial damaged skin layer.
StrataCTX helps to promote a moist healing environment for wounds or compromised skin. This moist wound healing environment promotes faster re-epithelialization and significantly reduces the skin’s acute inflammatory response.

Who can use StrataCTX ?

StrataCTX is intended to be used under the direction of healthcare practitioners in the management of cutaneous reactions. StrataCTX is indicated for children and people with sensitive skin. StrataCTX is intended for single patient use. It is ideal for large surface areas and contoured skin (e.g. head, face, hands and feet) as well as joints. It can also be used on hairy areas without the need to shave them.

StrataCTX is transparent allowing users to monitor therapy progress without having to remove the dressing.

StrataCTX is used to relieve low grade inflammatory changes such as dry, itching, flaking, peeling and irritated skin. In cases of more severe inflammatory changes, StrataCTX reduces pain, redness and heat sensation.

StrataCTX was developed for use on all types of wounds, toxic and compromised skin.

StrataCTX can be used with or without a secondary protective dressing.

How to open a StrataCTX tube

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

How to use StrataCTX

StrataCTX is recommended to be applied following the first day of treatment, or the first signs or symptoms on the skin. It should be applied until the skin condition is resolved or until no further improvement is seen.

StrataCTX should be applied at least twice daily to the affected areas, as needed or as required to maintain contact with the affected surface.

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

Directions for use

Step 1: Prepare your skin

Ensure that the affected superficial area is clean and dry.

Step 2: Apply StrataCTX

Apply a very thin layer of StrataCTX directly to the affected area and allow the gel to dry.

Step 3 A: Allow the gel to dry

When applied correctly, StrataCTX should be dry in 5 – 6 minutes.

If it takes longer to dry, you have probably applied too much. Gently remove any excess gel with a clean tissue, gauze or paper towel and allow the drying process to continue.

Step 4: You are ready to go!

Once dry, StrataCTX can be covered with clothes, sunscreen or cosmetics.

Additional directions

StrataCTX may be re-applied more often to ensure constant contact with the skin, or to reduce symptoms.

Washing will likely remove StrataCTX. Re-apply StrataCTX after each wash.

Areas with higher hygienic necessities (groin, perineum, anal). StrataCTX should be applied after each urination and bowel movement, on dry and clean skin.

StrataCTX does not need to be rubbed in or massaged, as it does not penetrate below the level of stratum corneum and will not enhance its effect.

StrataCTX can be applied directly to the skin, using the finger, Q-tip etc.

Removing StrataCTX

Any excess of StrataCTX on your hands can be easily removed by washing them with liquid soap and warm water. Repeat if necessary.

Removing from clothes

StrataCTX may stain clothing if not completely dry. If staining occurs, dry cleaning should be able to remove it without damaging the fabric.

Tips for StrataCTX usage

StrataCTX may be stored in the refrigerator prior to application for faster relief of symptoms.

StrataCTX can be used with or without a secondary protective dressing.

Recommended duration of treatment

StrataCTX is recommended as a treatment following the first signs or symptoms. It should be applied until the skin condition is resolved or until no further improvement is seen.

Dosage and administration

StrataCTX 1.75oz (50g)
is enough to treat an area of 6×12 inch (15×30 cm)
twice per day for 30 days.

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

Additional recommendations

Make sure your clothing covers the treated area when you are outside

Wear loose clothing

Choose clothes and bed sheets made of soft materials

Avoid direct sunlight. Sunscreen should be used for maximum protection from the sunlight

Use non-perfumed, mild soap and toiletries

Shower or bath with warm water and not with hot water

Gently pat your skin dry after taking a shower or bath

Avoid swimming in chlorinated water as it can have a drying effect on the skin

Use an electric razor if your doctor or nurse say you can shave

Do not “wet-shave” or use hair removal products

StrataCTX and other products

Moisturizers, lotions etc. are not required. StrataCTX can be re-applied more often to avoid dry and tight skin feeling, as StrataCTX prevents the water evaporation through the damaged skin that may cause this feeling. Alternatively, a moisturizer can be applied after StrataCTX dries to maintain the first contact of StrataCTX with the skin.

StrataCTX reduces the need for corticosteroids or antibiotics. StrataCTX reduces skin’s acute inflammatory response without side effects of corticosteroids or antibiotics. StrataCTX is bacteriostatic and prevents microbial and bacterial invasion without the risk of contact dermatitis.

IMPORTANT

Due to StrataCTX‘s semi-permeable nature:

• StrataCTX may enhance the effect of an active ingredient if StrataCTX is applied over the active ingredient.

• StrataCTX may prevent or reduce adsorption of active ingredients if that are applied over StrataCTX.

Additional prescribing information

Therapeutic group: Wound dressing for the management of cutaneous reactions.

Pharmaceutical form: Occlusive, non-resorbable, self-drying and transparent gel.

Description: When used as directed StrataCTX dries to form a protective layer that is gas permeable and waterproof which hydrates and protects compromised skin areas and superficial wounds from chemical and microbial invasion. StrataCTX helps to promote a moist healing environment. This moist wound healing environment promotes faster re-epithelialization* and reduces the skin’s acute inflammatory response.

Warnings: For external use only. StrataCTX should not be placed in contact with the eyes. StrataCTX should not be applied over topical medications unless advised by your physician. StrataCTX 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.

Side effects: At the time of producing this material, no adverse effects have been reported with the use of StrataCTX.

Drug interactions: None known.

Use in specific populations: No specific population restrictions, StrataCTX is suitable for children and people with sensitive skin.

Storage: Store at room temperature, out of direct sunlight.