Evesse

Evesse is an FDA-registered drug product whose active ingredient is HYDROCORTISONE BUTYRATE. It is labelled by Perfero Pharma, Inc. taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 87143-420, application ANDA209556, label effective 20260514. It is one of 3 FDA drug label records sharing the active ingredient HYDROCORTISONE BUTYRATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing HYDROCORTISONE BUTYRATE are most often described in connection with: evesse hydrocortisone, butyrate lotion, topical treatment, mild moderate, atopic dermatitis, patients months, corticosteroid indicated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE EVESSE™ (hydrocortisone butyrate) Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. EVESSE™ (hydrocortisone butyrate) Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )

2 DOSAGE AND ADMINISTRATION Apply EVESSE™ (hydrocortisone butyrate) Lotion for up to 2 weeks as a thin layer to the affected skin two times daily and rub in gently. Discontinue EVESSE™ (hydrocortisone butyrate) Lotion when control is achieved. If no improvement is seen within 2 weeks, consider reassessment of the diagnosis. Before prescribing for more than 2 weeks, the additional benefits of extending treatment up to 4 weeks should be weighed against the risk of endocrine system adverse reactions and local adverse reactions [see Warnings and Precautions (5.1) , Adverse Reactions (6.1 , 6.2) ] . EVESSE™ (hydrocortisone butyrate) Lotion is not for oral, ophthalmic, or intravaginal use. Do not use EVESSE™ (hydrocortisone butyrate) Lotion [see Warnings and Precautions (5.1) ] : 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. Apply a thin layer to the affected skin two times daily. ( 2 ) Rub in gently. ( 2 ) Discontinue EVESSE™ (hydrocortisone butyrate) Lotion when control is achieved. ( 2 ) Reassess diagnosis if no improvement is seen within 2 weeks. Before prescribing for more than 2 weeks, any additional benefits of extending treatment up to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse reactions. ( 2 ) Avoid use under occlusion or in the diaper area. ( 2 ) EVESSE™ (hydrocortisone butyrate) Lotion is not for oral, ophthalmic, or intravaginal use. ( 2 )

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: HPA axis suppression [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 Perfero Pharma, Inc. at 1-973-629-0109 and/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 practice. The safety data described below reflect exposure to Hydrocortisone Butyrate Lotion applied topically twice daily for up to 4 weeks in vehicle-controlled clinical trials of 284 pediatric subjects 3 months to 18 years of age and 301 adult subjects with mild to moderate atopic dermatitis [see Clinical Studies (14) ] . The incidence of selected adverse reactions reported by ≥1% of subjects during the studies is presented in Table 1 and Table 2. TABLE 1. Adverse Reactions in ≥1% of Hydrocortisone Butyrate Lotion-treated Pediatric Subjects 3 Months to 18 Years of Age with Mild to Moderate Atopic Dermatitis Hydrocortisone Butyrate Lotion (n=139) n (%) Vehicle (n=145) n (%) Application site reactions, including application site burning, pruritus, dermatitis, erythema, eczema, inflammation, or irritation 2 (1) 20 (14) Infantile acne 1 (1) 0 (0) Skin depigmentation 1 (1) 0 (0) TABLE 2. Adverse Reactions in ≥1% of Hydrocortisone Butyrate Lotion-treated Adult Subjects with Mild to Moderate Atopic Dermatitis Hydrocortisone Butyrate Lotion (n=151) n (%) Vehicle (n=150) n (%) Application site reactions, including application site burning, dermatitis, eczema, erythema, or pruritus 5 (3) 7 (5) 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of topical corticosteroids, including Hydrocortisone Butyrate Lotion. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Local Adverse Reactions: folliculitis, acneiform eruptions, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, miliaria, and telangiectasia. Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.

FDA lists 3 drug label records with HYDROCORTISONE BUTYRATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Evesse used for?
1 INDICATIONS AND USAGE EVESSE™ (hydrocortisone butyrate) Lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. EVESSE™ (hydrocortisone butyrate) Lotion is a corticosteroid indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. ( 1 )

Who makes Evesse?
Perfero Pharma, Inc. is the labeler of record for Evesse. 3 FDA label records share the active ingredient HYDROCORTISONE BUTYRATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Evesse come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Evesse prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing HYDROCORTISONE BUTYRATE?
Yes. 3 FDA drug label records list HYDROCORTISONE BUTYRATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Evesse been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.