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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.

See Tables 1, 2, and 3 below.

Table 1: Percent of Positive Reactions to Nickel Sulfate

Total Occlusion Test Site 6 Hrs 24Hrs 48 Hrs 96 Hrs
N % N % N % N %
6 Hour Tetrix + Antigen 0 0.0 2 16.7 5 41.7 5 41.7
Antigen 0 0.0 3 25.0 6 50.0 6 50.0
24 Hour Tetrix + Antigen     5 41.7 9 75.0 9 75.0
Antigen     8 66.7 9 75.0 9 75.0
48 Hour Tetrix + Antigen         11 91.7 11 91.7
Antigen         12 100 12 100
White Petrolatum         0 0.0 0 0.0

12 subjects were exposed to nickel sulfate and included in the analysis.
The N in each column refers to the number of subjects with positive reactions.

Table 2: Percent of Positive Reactions to Neomycin

Total Occlusion Test Site 6 Hrs 24Hrs 48 Hrs 96 Hrs
N % N % N % N %
6 Hour Tetrix + Antigen 0 0.0 1 8.3 0 0.0 3 25.0
Antigen 2 16.7 0 0.0 1 8.3 4 33.3
24 Hour Tetrix + Antigen     0 0.0 2 16.7 9 75.0
Antigen     2 16.7 4 33.3 10 83.3
48 Hour Tetrix + Antigen         4 33.3 8 66.7
Antigen         6 50.0 12 100
White Petrolatum         1 8.3 0 0.0

12 subjects were exposed to neomycin and included in the analysis.
The N in each column refers to the number of subjects with positive reactions.

Table 3: Percent of Positive Reactions to Fragrance Mix

Total Occlusion Test Site 6 Hrs

24Hrs 48 Hrs 96 Hrs
N % N % N % N %
6 Hour Tetrix + Antigen 0 0.0 3 27.3 5 45.5 5 45.5
Antigen 0 9.1 7 63.6 5 45.5 6 54.5
24 Hour Tetrix + Antigen     5 45.5 6 54.5 7 63.6
Antigen     10 90.9 9 81.8 9 81.8
48 Hour Tetrix + Antigen         6 81.8 9 81.8
Antigen         10 90.9 10 90.9
White Petrolatum         1 9.1 0 0.0

12 subjects were exposed to fragrance mix and included in the analysis.
The N in each column refers to the number of subjects with positive reactions.

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 AE@encorederm.com, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

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