Adapalene Gel label

Adapalene Gel

Adapalene Gel Recall

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Adapalene gel, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

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History

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Other Information

Adapalene gel, 0.3% contains Active: adapalene 0.3% (3 mg/g) in a topical aqueous gel for use in the treatment of acne vulgaris. Inactive: consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 124, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid for pH adjustment. The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. It is a white to off-white powder, which is soluble in tetrahydrofuran, very slightly soluble in ethanol, and practically insoluble in water. The molecular formula is C28H28O3 and molecular weight is 412.53. Adapalene is represented by the following structural formula.

owen-adap-gel-chem

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Adapalene Gel Manufacturers

  • Owen Laboratories, Inc.
    Adapalene Gel | Owen Laboratories, Inc.
    No Recall

    Adapalene Gel | Owen Laboratories, Inc.

    Adapalene Gel | Owen Laboratories, Inc.

    Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene gel, 0.3%. Patients should be instructed to minimize sun exposure. Patients may be instructed to use moisturizers for relief of dry skin or irritation. If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated. For topical use only. Not for ophthalmic, oral or intravaginal use.

  • Physicians Total Care, Inc.
    Adapalene Gel | Physicians Total Care, Inc.
    No Recall

    Adapalene Gel | Physicians Total Care, Inc.

    Adapalene Gel | Physicians Total Care, Inc.

    Adapalene Gel should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes.

    During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.

  • Taro Pharmaceuticals U.s.a., Inc.
    Adapalene Gel | Taro Pharmaceuticals U.s.a., Inc.
    No Recall

    Adapalene Gel | Taro Pharmaceuticals U.s.a., Inc.

    Adapalene Gel | Taro Pharmaceuticals U.s.a., Inc.

    Adapalene gel should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes.

    During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.

  • Teva Pharmaceuticals Usa Inc
    Adapalene Gel | Teva Pharmaceuticals Usa Inc
    No Recall

    Adapalene Gel | Teva Pharmaceuticals Usa Inc

    Adapalene Gel | Teva Pharmaceuticals Usa Inc

    Adapalene Gel should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes.

    During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.

  • Glenmark Generics Inc., Usa
    Adapalene Gel | Westagro, Inc.
    No Recall

    Adapalene Gel | Westagro, Inc.

    Adapalene Gel | Westagro, Inc.

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

  • Prasco Laboratories
    Adapalene Gel | Prasco Laboratories
    No Recall

    Adapalene Gel | Prasco Laboratories

    Adapalene Gel | Prasco Laboratories

    Apply a thin film of Adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap. Avoid application to the areas of skin around eyes, lips, and mucous membranes. A mild transitory sensation of warmth or slight stinging may occur shortly after the application of Adapalene gel, 0.3%. Patients should be instructed to minimize sun exposure. Patients may be instructed to use moisturizers for relief of dry skin or irritation.

    If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated.

    For topical use only. Not for ophthalmic, oral or intravaginal use.

  • Sandoz Inc.
    Adapalene Gel | Sandoz Inc.
    No Recall

    Adapalene Gel | Sandoz Inc.

    Adapalene Gel | Sandoz Inc.

    Apply a thin film of adapalene gel, 0.3% to the entire face and any other affected areas of the skin once daily in the evening, after washing gently with a non-medicated soap.  Avoid application to the areas of skin around eyes, lips, and mucous membranes.  A mild transitory sensation of warmth or slight stinging may occur shortly after the application of adapalene gel, 0.3%.  Patients should be instructed to minimize sun exposure.  Patients may be instructed to use moisturizers for relief of dry skin or irritation.

    If therapeutic results are not noticed after 12 weeks of treatment, therapy should be re-evaluated.

    For topical use only.  Not for ophthalmic, oral or intravaginal use.

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