Tretinoin Gel Microsphere label

Tretinoin Gel Microsphere

Tretinoin Gel Microsphere Recall

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Tretinoin Gel Microsphere, 0.1% and 0.04% is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the use of this product in the treatment of other disorders have not been established.

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History

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Other Information

Tretinoin Gel Microsphere, 0.1% and 0.04% is a formulation containing 0.1% or 0.04%, by weight, tretinoin for topical treatment of acne vulgaris. This formulation uses patented methyl methacrylate/glycol dimethacrylate crosspolymer porous microspheres (MICROSPONGE® System) to enable inclusion of the active ingredient, tretinoin, in an aqueous gel. Other components of this formulation are purified water, carbomer 974P (0.04% formulation), carbomer 934P (0.1% formulation), glycerin, disodium EDTA, propylene glycol, sorbic acid, PPG-20 methyl glucose ether distearate, cyclomethicone and dimethicone copolyol, benzyl alcohol, trolamine, and butylated hydroxtoluene.

Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraenoic acid. It is a member of the retinoid family of compounds, and a metabolite of naturally occurring Vitamin A. Tretinoin has a molecular weight of 300.44. Tretinoin has the following structure:

Chemical Structure
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Tretinoin Gel Microsphere Manufacturers

  • Spear Dermatology Products Inc
    Tretinoin Gel Microsphere | Spear Dermatology Products Inc
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    Tretinoin Gel Microsphere | Spear Dermatology Products Inc

    Tretinoin Gel Microsphere | Spear Dermatology Products Inc

    Tretinoin Gel Microsphere, 0.1% and 0.04% should be applied once a day, in the evening, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Application of excessive amounts of gel may result in "caking" of the gel, and will not provide incremental efficacy.

    A transitory feeling of warmth or slight stinging may be noted on application. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or the frequency of application increased as the patient becomes able to tolerate the treatment. Frequency of application should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. Efficacy has not been established for less than once daily dosing frequencies.

    During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. If tolerated, this should not be considered a reason to discontinue therapy. Therapeutic results may be noticed after two weeks, but more than seven weeks of therapy are required before consistent beneficial effects are observed.

    Patients treated with Tretinoin Gel Microsphere, 0.1% and 0.04% may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied.

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