Clobetasol Propionate Emulsion label

Clobetasol Propionate Emulsion

Clobetasol Propionate Emulsion 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

Clobetasol propionate emollient cream, 0.05% is a super-high potency corticosteroid indicated for:

1.1 Corticosteroid-Responsive Dermatoses

Clobetasol propionate emollient cream, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of cortico-steroid-responsive dermatoses in patients 12 years of age and older. Treatment should be limited to 2 consecutive weeks, and the total dosage should not exceed 50 grams per week.

1.2 Moderate to Severe Plaque-Type Psoriasis

Clobetasol propionate emollient cream USP, 0.05% is indicated for the topical treatment of moderate to severe plaque-type psoriasis. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age is not recommended.

1.3 Limitations of Use

Clobetasol propionate emollient cream, 0.05% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.

The total dosage should not exceed 50 grams per week.

Avoid use if skin atrophy is present at the treatment site.

History

There is currently no drug history available for this drug.

Other Information

Clobetasol Propionate Emollient Cream, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Chemically, clobetasol propionate is (11β,16β)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4-diene-3,20-dione, and it has the following structural formula:

Chemical Structure

Clobetasol propionate has the molecular formula C25H32ClFO5 and a molecular weight of 467. It is a white to cream colored crystalline powder insoluble in water.

Each gram of Clobetasol Propionate Emollient Cream, 0.05% contains clobetasol propionate 0.5 mg/g in an emollient base of cetomacrogol 1000, cetostearyl alcohol, citric acid, dimethicone 360, imidurea as a preservative, isopropyl myristate, propylene glycol, purified water, and sodium citrate.

Clobetasol Propionate Emulsion Manufacturers

  • Clobetasol Propionate Emulsion | Hi-tech Pharmacal Co., Inc.
    No Recall

    Clobetasol Propionate Emulsion | Hi-tech Pharmacal Co., Inc.

    Clobetasol Propionate Emulsion | Hi-tech Pharmacal Co., Inc.

    Apply a thin layer of clobetasol propionate emollient cream, 0.05% to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application.

    Clobetasol propionate emollient cream, 0.05% is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used.

    In moderate to severe plaque-type psoriasis, clobetasol propionate emollient cream, 0.05% applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended.

    Clobetasol propionate emollient cream, 0.05% should not be used with occlusive dressings.

  • Physicians Total Care, Inc.
    Clobetasol Propionate Emulsion | Physicians Total Care, Inc.
    No Recall

    Clobetasol Propionate Emulsion | Physicians Total Care, Inc.

    Clobetasol Propionate Emulsion | Physicians Total Care, Inc.

    Apply a thin layer of clobetasol propionate cream-emollient, 0.05% to the affected skin areas twice daily and rub in gently and completely (see INDICATIONS AND USAGE).

    Clobetasol propionate cream-emollient is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks and amounts greater than 50 g/week should not be used.

    In moderate to severe plaque-type psoriasis, clobetasol propionate cream-emollient applied to 5% to 10% of body surface area can be used up to 4 weeks. The total dosage should not exceed 50 g/week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended. Use in pediatric patients under 16 years of age has not been studied.

    Clobetasol propionate cream-emollient should not be used with occlusive dressings.

    Geriatric Use

    In studies where geriatric patients (65 years of age or older, see PRECAUTIONS) have been treated with clobetasol propionate cream-emollient, safety did not differ from that in younger patients; therefore, no dosage adjustment is recommended.

  • Prasco Laboratories
    Clobetasol Propionate Emulsion | Salado Sales, Inc.
    No Recall

    Clobetasol Propionate Emulsion | Salado Sales, Inc.

    Clobetasol Propionate Emulsion | Salado Sales, Inc.
    do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage
  • Renaissance Pharma, Inc.
    Clobetasol Propionate Emulsion | Renaissance Pharma, Inc.
    No Recall

    Clobetasol Propionate Emulsion | Renaissance Pharma, Inc.

    Clobetasol Propionate Emulsion | Renaissance Pharma, Inc.

    Clobetasol Propionate Emulsion Foam is not for oral, ophthalmic, or intravaginal use.

    Apply a thin layer of Clobetasol Propionate Emulsion Foam to the affected area(s) twice daily, morning and evening, for up to 2 consecutive weeks; therapy should be discontinued when control has been achieved. The maximum weekly dose should not exceed 50 g or an amount greater than 21 capfuls per week. For proper dispensing of foam, shake the can, hold it upside down, and depress the actuator. Dispense a small amount of foam (about a capful) and gently massage the medication into the affected areas (excluding the face, groin, and axillae) until the foam is absorbed. Avoid contact with the eyes.