Hydrocortisone Butyrate

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Hydrocortisone Butyrate Recall

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Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Hydrocortisone butyrate cream USP, 0.1% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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History

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Other Information

Hydrocortisone Butyrate Cream USP, 0.1% contains the topical corticosteroid hydrocortisone butyrate, a non-fluorinated hydrocortisone ester. It has the chemical name: pregn-4-ene-3,20-dione, 11,21 - dihydroxy-17-[(1-oxobutyl)oxy]-, (11β-); the molecular formula: C25H36O6; the molecular weight: 432.54; and the CAS registry number: 13609-67-1.

Its structural formula is:

Each gram of hydrocortisone butyrate cream USP, 0.1% contains 1.0 mg of hydrocortisone butyrate in a hydrophilic base consisting of cetostearyl alcohol, ceteth-20, mineral oil, white petrolatum, citric acid, sodium citrate, propylparaben and butylparaben (preservatives) and purified water.

Sources

Hydrocortisone Butyrate Manufacturers

Physicians Total Care, Inc.

Hydrocortisone Butyrate | Physicians Total Care, Inc.

Hydrocortisone butyrate cream USP, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Rebel Distributors Corp

Hydrocortisone Butyrate | Rebel Distributors Corp

Hydrocortisone butyrate cream USP, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Metacon Labs

Hydrocortisone Butyrate | Metacon Labs

Hydrocortisone Butyrate Cream (lipid) 0.1% is not for oral, ophthalmic, or intravaginal use.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of Hydrocortisone Butyrate Cream (lipid) 0.1% has not been established beyond 4 weeks of use.
2.1 Corticosteroid-Responsive Dermatoses in Adults
Apply a thin film to the affected skin areas two or three times daily, depending on the severity of the condition. Rub in gently.
2.2 Atopic Dermatitis in Patients From 3 Month to 18 Years
Apply a thin film to the affected skin areas two times daily. Rub in gently.

Hydrocortisone Butyrate Cream (lipid) 0.1% should not be used with occlusive dressings or applied in the diaper area unless directed by a physician.

No Recall
Glenmark Generics Inc.,usa

Hydrocortisone Butyrate | Glenmark Generics Inc.,usa

Hydrocortisone butyrate cream, 0.1% (lipophilic) is not for oral, ophthalmic, or intravaginal use. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of hydrocortisone butyrate cream, 0.1% (lipophilic) has not been established beyond 4 weeks of use.
2.1 Corticosteroid-Responsive Dermatoses in Adults
Apply a thin film to the affected skin areas two or three times daily, depending on the severity of the condition. Rub in gently.
2.2 Atopic Dermatitis in Patients From 3 Month to 18 Years
Apply a thin film to the affected skin areas two times daily. Rub in gently.

Hydrocortisone butyrate cream, 0.1% (lipophilic) should not be used with occlusive dressings or applied in the diaper area unless directed by a physician.

No Recall
Remedyrepack Inc.

Hydrocortisone Butyrate | Remedyrepack Inc.

Hydrocortisone butyrate cream USP, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Rouses Point Pharm

Hydrocortisone Butyrate | Rouses Point Pharm

Hydrocortisone butyrate cream USP, 0.1% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

No Recall
Oceanside Pharmaceuticals

Hydrocortisone Butyrate | Oceanside Pharmaceuticals

For corticosteroid-responsive dermatoses in adults, apply a thin film to the affected skin areas two or three times daily, depending on the severity of the condition, and rub in gently.

For atopic dermatitis in patients 3 months to 18 years of age, apply a thin film to the affected skin areas two times daily, and rub in gently. Do not apply Hydrocortisone Butyrate Cream (lipid), 0.1% in the diaper area unless directed by a physician.

Discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of Hydrocortisone Butyrate Cream (lipid), 0.1% has not been established beyond 4 weeks of use [see Warnings and Precautions (5.1)].

Do not use Hydrocortisone Butyrate Cream (lipid), 0.1% with occlusive dressings unless directed by a physician. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings.

Hydrocortisone Butyrate Cream (lipid), 0.1% is not for oral, ophthalmic, or intravaginal use.

No Recall