Hydrocortisone Butyrate is a corticosteroid sold in the U.S. under 2 brand and generic names, for contact dermatitis, facial dermatoses and foot dermatoses. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Locoid Lipocream (application NDA020769). Other hydrocortisone butyrate products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended Dosage for Corticosteroid-Responsive Dermatoses For corticosteroid-responsive dermatoses in adults, apply a thin layer to the affected skin areas 2 or 3 times daily, depending on the severity of the condition, and rub in gently. Recommended Dosage for Atopic Dermatitis For atopic dermatitis in patients 3 months of age and older, apply a thin layer to the affected skin areas 2 times daily and rub in gently. Administration Instructions 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, weigh any additional benefits of extending treatment to 4 weeks against the risk of HPA-axis suppression and local adverse events [see Warnings and Precautions ( 5.1 )] . Hydrocortisone Butyrate Cream (lipid), 0.1% is not for oral, ophthalmic, or intravaginal use. Do not use Hydrocortisone Butyrate Cream (lipid), 0.1%: With occlusive dressings unless directed by a healthcare provider. Avoid use in the diaper area, as diapers or plastic pants may constitute occlusive dressings. On the face, underarms, or groin areas unless directed by a healthcare provider. Corticosteroid-Responsive Dermatoses: Apply a thin layer to the affected skin areas 2 or 3 times daily for corticosteroid-responsive dermatoses in adults. Rub in gently. ( 2 ) Atopic Dermatitis: Apply a thin…
The following adverse reactions are discussed in greater detail in other sections of the labeling: Endocrine system adverse reactions [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.4 )] Ophthalmic adverse reactions [see Warnings and Precautions ( 5.2 )] Skin infections [see Warnings and Precautions ( 5.3 )] Allergic contact dermatitis [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (≥1%) are application site reactions. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data derived from Hydrocortisone Butyrate Cream (lipid), 0.1% clinical trials reflect exposure to Hydrocortisone Butyrate Cream (lipid), 0.1% twice daily for up to 4 weeks in pediatric subjects 3 months of age and older with mild to moderate atopic dermatitis. Table 1. Frequency of Adverse Reactions in Pediatric Subjects 3 Months of Age and Older with Mild to Moderate Atopic Dermatitis Hydrocortisone Butyrate Cream (lipid), 0.1% (n=131) Vehicle (n=133)…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | Not yet rated | Prescription | Topical | — | — | View → | |
| 2 | Not yet rated | Prescription | Topical | — | — | View → |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None. None. ( 4 )