TL-Cermide Skin Emulsion

TRIGEN Laboratories, Inc.

TL-Cermide

FULL PRESCRIBING INFORMATION: CONTENTS*

• Description
• INDICATIONS FOR USE
• TL-CERMIDE SKIN EMULSION CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS AND OBSERVATIONS
• INSTRUCTIONS FOR USE
• INGREDIENTS
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

Description

TL-Cermide^TM Skin Emulsion is a steroid-free, fragrance-free, ceramide-dominant formulation.

INDICATIONS FOR USE

TL-Cermide^TM Skin Emulsion is to be used to treat dry skin conditions and to manage and relieve the burning and itching associated with various types of dermatitis, including atopic dermatitis, irritant contact dermatitis, and radiation dermatitis. TL-Cermide^TM Skin Emulsion helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

TL-CERMIDE SKIN EMULSION CONTRAINDICATIONS

TL-Cermide^TM Skin Emulsion is contraindicated in persons with known hypersensitivity to any of the components of the formulation.

WARNINGS

TL-Cermide^TM Skin Emulsion does not contain a sunscreen and should always be used in conjunction with a sunscreen in sun exposed areas. In radiation dermatitis and/or in conjunction with ongoing radiation therapy, apply following radiation therapy. Apply twice daily or as indicated by the radiation therapist. After application, a temporary tingling sensation may occur (10 to 15 minutes). Keep this and similar products out of the reach of children. Follow directions for use. If condition does not improve within 10 to 14 days, consult a physician.

PRECAUTIONS AND OBSERVATIONS

For the treatment of any dermal wound, consult a physician.

• Use TL-Cermide^TM Skin Emulsion only as directed.
• TL-Cermide^TM Skin Emulsion is non-toxic; however, it is for external use only and should not be ingested or taken internally
• If clinical signs of infection are present, appropriate treatment should be initiated. If clinically indicated, use of TL-Cermide^TM Skin Emulsion may be continued during the anti-infective therapy
• If the condition does not improve within 10 to 14 days, consult a physician
• TL-Cermide^TM Skin Emulsion does not contain a sunscreen and should always be used in conjunction with a sunscreen in sun exposed areas
• In radiation dermatitis and/or in conjunction with ongoing radiation therapy, apply following radiation therapy
• Do not apply within 4 hours prior to radiation therapy
• Apply twice daily or as indicated by the radiation therapist
• Following the application of TL-Cermide^TM Skin Emulsion a temporary tingling sensation may occur (10 to 15 minutes)
• Keep this and other similar products out of the reach of children

INSTRUCTIONS FOR USE

Apply a thin layer to the affected areas 2 times per day (or as needed) and massage gently into the skin. If the skin is broken, cover TL-Cermide^TM Skin Emulsion, with a dressing of choice.

INGREDIENTS

Purified Water, Sodium Hydroxypropyl Starch Phosphate, Petrolatum, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Squalane, Corn Syrup Solids, Dimethicone, E. Cerifera (Candelilla) Wax, Hydroxypropyl Bispalmitamide MEA (Ceramide), Phenoxyethanol, Cholesterol, Xanthan Gum, Capric Acid, Citric Acid, Disodium EDTA, Palmitic Acid, Potassium Hydroxide, and Sorbic Acid.

HOW SUPPLIED

TL-Cermide^TM Skin Emulsion is available in a 90-gram tube.

Product Code: 13811-566-90

STORAGE

Store at controlled room temperature 15°C - 30°C (59°F - 86°F). [See USP]. Do not freeze.

Call your doctor about side effects.

You may report side effects by calling 888 9 TRIGEN (888-987-4436).

KEEP OUT OF THE REACH OF CHILDREN.

R_x Only - Prescription Medical Device: Federal Law restricts this device to sale by or on the order of a physician (or properly licensed practitioner).

Manufactured for

TRIGEN Laboratories, Inc.

Sayreville, NJ 08872

www.trigenlab.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 90 Gram Carton Label

13811-566-90

Rx Only

TL-Cermide^TM Skin Emulsion

For Topical Dermatological Use Only

TRIGEN LABORATORES

Net Wt. 90g

For External Use Only

Store at controlled room temperature 15°C - 30°C (59°F - 86°F). [See USP]. Do not freeze.

Warning: KEEP OUT OF THE REACH OF CHILDREN

See enclosed insert for complete product information.

See bottom of carton for lot and expiration date

Manufactured for

TRIGEN Laboratories, Inc.

Sayreville, NJ 08872

www.trigenlab.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 90 Gram Tube Label

13811-566-90

Rx Only

TL-Cermide^TM Skin Emulsion

For Topical Dermatological Use Only

TRIGEN LABORATORES

Net Wt. 90g

For External Use Only

Store at controlled room temperature 15°C - 30°C (59°F - 86°F). [See USP]. Do not freeze.

Warning: KEEP OUT OF THE REACH OF CHILDREN

See enclosed insert for complete product information.

See crimp for lot and expiration date

Manufactured for

TRIGEN Laboratories, Inc.

Sayreville, NJ 08872

www.trigenlab.com