Evesse 1 mg/mL

hydrocortisone butyrate · LOTION · Perfero Pharma, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Evesse is a lotion containing hydrocortisone butyrate at 1 mg/mL, taken topical. Manufactured by Perfero Pharma, Inc..

Key Facts

Brand Name: Evesse
Generic Name: hydrocortisone butyrate
NDC Code (Product): 87143-420
Manufacturer: Perfero Pharma, Inc.
Strength: 1 mg/mL
Dosage Form: LOTION
Route: TOPICAL
Marketing Status
Application #: ANDA209556
Marketing Start: 05/04/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use573 reports

drug ineffective519 reports

infusion related reaction513 reports

rash504 reports

fatigue503 reports

glossodynia497 reports

systemic lupus erythematosus487 reports

hand deformity484 reports

duodenal ulcer perforation480 reports

joint swelling472 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 )

Dosage & Administration

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 ) Reas…

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Adverse Reactions

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…

Frequently Asked Questions

What is Evesse used for?

Evesse contains hydrocortisone butyrate. It is a lotion taken topical. Consult your doctor for specific uses.

Is Evesse a controlled substance?

Evesse is not classified as a controlled substance by the DEA.

What is the generic name for Evesse?

The generic name for Evesse is hydrocortisone butyrate. There are 9 other brand versions of hydrocortisone butyrate.

What is the NDC code for Evesse 1 mg/mL?

The NDC (National Drug Code) for Evesse 1 mg/mL is 87143-420, listed by Perfero Pharma, Inc..

Product NDC

87143-420

Package NDC

87143-420-04

Other Hydrocortisone Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)