Avita label

Avita

Avita Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

AVITA® Cream is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of this product in the treatment of other disorders have not been established.

History

There is currently no drug history available for this drug.

Other Information

AVITA® Cream, a topical retinoid, contains tretinoin 0.025% by weight in a hydrophilic cream vehicle of stearic acid, polyolprepolymer-2, isopropyl myristate, polyoxyl 40 stearate, propylene glycol, stearyl alcohol, xanthan gum, sorbic acid, butylated hydroxytoluene, and purified water. Chemically, tretinoin is all-transretinoic acid (C20H2802; molecular weight 300.44 vitamin A acid) and has the following structural formula:

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Avita Manufacturers

  • Mylan Bertek Pharmaceuticals Inc.
    Avita | Mylan Bertek Pharmaceuticals Inc.
    No Recall

    Avita | Mylan Bertek Pharmaceuticals Inc.

    Avita | Mylan Bertek Pharmaceuticals Inc.

    AVITA® Cream 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 may cause a transient feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alterations of dose frequency 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 increase in number and exacerbation of inflammatory acne lesions may occur. This is due, in part, to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks but more than six weeks of therapy may be required before definite beneficial effects are seen. Patients treated with AVITA® Cream may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied (see Precautions Section).

  • Mylan Pharmaceuticals Inc.
    Avita | Air Liquide Healthcare America Corporation
    No Recall

    Avita | Air Liquide Healthcare America Corporation

    Avita | Air Liquide Healthcare America Corporation

    There is currently no dosage information available for this product. We apologize for any inconvenience.

  • Mylan Pharmaceuticals Inc.
    Avita | Mylan Pharmaceuticals Inc.
    No Recall

    Avita | Mylan Pharmaceuticals Inc.

    Avita | Mylan Pharmaceuticals Inc.

    AVITA® Gel 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 may cause a transient feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alterations of dose frequency 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 increase in number and exacerbation of inflammatory acne lesions may occur. This is due, in part, to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after two to three weeks, but more than six weeks of therapy may be required before definite beneficial effects are seen. Patients treated with AVITA® Gel may use cosmetics, but the areas to be treated should be cleansed thoroughly before the medication is applied (see Precautions Section).