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Elocon

Elocon 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

ELOCON Cream 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

ELOCON (mometasone furoate cream) Cream 0.1% may be used in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established (see PRECAUTIONS – Pediatric Use section). Since safety and efficacy of ELOCON Cream 0.1% have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.

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History

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Other Information

ELOCON® (mometasone furoate cream) Cream 0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.

Chemically, mometasone furoate is 9α,21-Dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30Cl2O6, a molecular weight of 521.4 and the following structural formula:

image of chemical structure

Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.

Each gram of ELOCON Cream 0.1% contains: 1 mg mometasone furoate, USP in a cream base of hexylene glycol, phosphoric acid, propylene glycol stearate (55% monoester), stearyl alcohol and ceteareth-20, titanium dioxide, aluminum starch octenylsuccinate (Gamma Irradiated), white wax, white petrolatum, and purified water.

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Elocon Manufacturers

  • Physicians Total Care, Inc.
    Elocon | Physicians Total Care, Inc.
    No Recall

    Elocon | Physicians Total Care, Inc.

    Elocon | Physicians Total Care, Inc.

    Apply a thin film of ELOCON Cream 0.1% to the affected skin areas once daily. ELOCON Cream 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of ELOCON Cream 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see PRECAUTIONS – Pediatric Use section).

    As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of ELOCON Cream 0.1% in pediatric patients for more than 3 weeks of use have not been established.

    ELOCON Cream 0.1% should not be used with occlusive dressings unless directed by a physician. ELOCON Cream 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.

  • Merck Sharp & Dohme Corp.
    Elocon | Merck Sharp & Dohme Corp.
    No Recall

    Elocon | Merck Sharp & Dohme Corp.

    Elocon | Merck Sharp & Dohme Corp.

    Apply a thin film of ELOCON Ointment to the affected skin areas once daily.

    Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

    Safety and efficacy of ELOCON Ointment in pediatric patients for more than 3 weeks of use have not been established [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

    ELOCON Ointment should not be used with occlusive dressings unless directed by a physician. ELOCON Ointment should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

    ELOCON Ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

    Avoid use on the face, groin, or axillae.

  • Merck Sharp & Dohme Corp.
    Elocon | Merck Sharp & Dohme Corp.
    No Recall

    Elocon | Merck Sharp & Dohme Corp.

    Elocon | Merck Sharp & Dohme Corp.

    Apply a few drops of ELOCON Lotion to the affected skin areas once daily and massage lightly until it disappears.

    Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

    ELOCON Lotion should not be used with occlusive dressings unless directed by a physician. ELOCON Lotion should not be applied in the diaper area if the patient still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

    ELOCON Lotion is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

    Avoid use on the face, groin, or axillae.

  • Merck Sharp & Dohme Corp.
    Elocon | Merck Sharp & Dohme Corp.
    No Recall

    Elocon | Merck Sharp & Dohme Corp.

    Elocon | Merck Sharp & Dohme Corp.

    Apply a thin film of ELOCON Cream to the affected skin areas once daily. ELOCON Cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of ELOCON Cream have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

    Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of ELOCON Cream in pediatric patients for more than 3 weeks of use have not been established.

    ELOCON Cream should not be used with occlusive dressings unless directed by a physician. ELOCON Cream should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

    ELOCON Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

    Avoid use on the face, groin, or axillae.

  • A-s Medication Solutions Llc
    Elocon | A-s Medication Solutions Llc
    No Recall

    Elocon | A-s Medication Solutions Llc

    Elocon | A-s Medication Solutions Llc

    Apply a thin film of ELOCON Cream to the affected skin areas once daily. ELOCON Cream may be used in pediatric patients 2 years of age or older. Since safety and efficacy of ELOCON Cream have not been established in pediatric patients below 2 years of age; use in this age group is not recommended [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].

    Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of ELOCON Cream in pediatric patients for more than 3 weeks of use have not been established.

    ELOCON Cream should not be used with occlusive dressings unless directed by a physician. ELOCON Cream should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

    ELOCON Cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

    Avoid use on the face, groin, or axillae.

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