RX ITEM-Tetrix Cream Cream 4 Oz By Valeant Pharma

Prescribing Information Tetrix� Cream

Rx Only

Product Description
Tetrix� Cream is a non-sterile cream formulation intended for prescription use only.

Clinical studies provided evidence that Tetrix� Cream prevents nickel salts, neomycin and a mixture of fragrances from making contact with the skin. Please see Clinical Studies section.

Indications and Usage
Tetrix� Cream is intended to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. Tetrix� Cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Directions for Use
Apply a thin layer to affected areas 2-3 times per day or as directed by a physician.

Clinical Studies
A non-randomized, investigator blinded, single-site controlled clinical study included 35 patients with known sensitivities to nickel sulfate, neomycin, and/or a mixture of fragrances. The study intended to determine whether Tetrix� Cream acts as a barrier against these 3 antigens when compared to antigen alone and white petrolatum. The study showed that application of Tetrix� Cream to the skin provides a barrier against sensitization caused by nickel sulfate, neomycin, and a mixture of fragrances for up to 48 hours post-occlusion.
Ingredients
Tetrix� Cream is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, dimethicone, hexyl laurate, polyglyceryl-4-isostearate, purified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives.

Contraindications
Tetrix� Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

Precautions
For external use only. Avoid contact with eyes and other mucous membranes. Do not use the product if the packaging is damaged or after the expiration date. If your condition does not improve within 10-14 days, consult your physician. The safety and efficacy of Tetrix� Cream has not been determined in pediatric patients.

Keep out of the reach of children.

Tetrix� Cream contains no dyes or fragrances and is well tolerated and safe.

How Supplied
Tetrix� Cream is available In a 2 fl. oz. (56.7 g) tube.

Store at controlled room temperature: 15�C to 30�C (59�F to 86�F). Do not freeze.

To report SUSPECTED ADVERSE REACTIONS, contact Encore Dermatology at 844-848-6543, Option 1 or [email protected], or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

RX ITEM-Tetrix Cream Cream 4 Oz By Valea
NDC 08569-0000-03 UPC/GTIN No.8-56900-00030-1 Mfg.Part No.08569-0000-03

Tetrix Cream Cream 4 Oz By Valeant Pharm
BRAND: TETRIX M NDC: 08569-0000-03,8569000003 UPC: 8-56900-00030-1,856900000301 Valeant Pharma

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