FDA-filed SPL labeling · retrieved through openFDA

Crisaborole Topical

Crisaborole is a topical anti-inflammatory medicine used to treat mild to moderate atopic dermatitis (eczema) in adults and children 3 months of age and older.

Brand name Eucrisa
Drug class Phosphodiesterase 4 Inhibitor
Rx Form 1 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveSep 23, 2025
AvailabilityRx
Earliest approval/marketing year 2016
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 21, 2026
Crisaborole Topical at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Eucrisa (crisaborole) is a non-steroid prescription ointment that treats mild to moderate atopic dermatitis (eczema) in adults and children as young as 3 months old. The most common side effect is a brief burning or stinging sensation where you apply it. Stop using it and contact your doctor or seek care right away if you develop signs of a serious allergic reaction, such as significant swelling, hives, or intense redness.

📖 Crisaborole Topical: Patient Information Guide

A plain-language walkthrough of Crisaborole Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Crisaborole is a topical medicine approved for the following use:

  • Eucrisa ointment is indicated for the topical treatment of mild to moderate atopic dermatitis (eczema) in adults and in pediatric patients 3 months of age and older.
⚙️How it works

Crisaborole belongs to a class of medicines called PDE-4 inhibitors (phosphodiesterase 4 inhibitors). It works by blocking the PDE-4 enzyme inside skin cells. Blocking this enzyme raises levels of a molecule called cyclic AMP (cAMP), which helps reduce the inflammatory signals that drive eczema flares. The precise downstream steps that lead to skin improvement are not yet fully defined.

💊How it's taken

Eucrisa ointment is applied directly to the skin — not taken by mouth. A thin layer is applied to affected areas twice a day. Once your skin responds well, your prescriber may recommend cutting back to once daily.

  • Apply only to affected skin areas.
  • Keep it away from the eyes, mouth, and vaginal area.
  • Follow your prescriber's directions — do not apply more often than instructed.
🤒Side effects — in detail

The most commonly reported side effect with Eucrisa is discomfort at the spot where you apply it:

  • Application site pain — burning or stinging (reported in about 4% of users in clinical trials)
  • Application site infection (less common)
  • Application site dermatitis — irritation or inflammation at the application site (less common)

Serious allergic reactions, including hives and swelling, have been reported. Stop using Eucrisa immediately and seek medical help if you notice severe itching, swelling, or redness at or away from the application site.

⚠️Warnings & precautions
  • Allergic reactions: Some people have had hypersensitivity reactions — including contact urticaria (hives) — while using Eucrisa. Watch for severe itching, swelling, or redness at the application site or elsewhere on the body. If this happens, stop the medicine right away and get medical care.
  • Skin use only: Eucrisa must not be applied to the eyes, mouth, or vaginal area.
  • Systemic absorption: A small amount of crisaborole is absorbed through the skin into the bloodstream, which is something your doctor considers when weighing its use, especially in pregnant or breastfeeding patients.
🔀What it interacts with

Based on laboratory studies, crisaborole is not expected to cause clinically significant interactions with most common medications when used as directed on the skin. One specific point worth knowing:

  • A breakdown product of crisaborole may interact with certain drugs processed by the UGT1A9 enzyme (a liver processing pathway), potentially raising the levels of those medications — though this has not been shown to be a problem in clinical use at standard doses.
  • Studies including warfarin (a blood thinner) showed no meaningful interaction with crisaborole.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Allergy to crisaborole: Do not use Eucrisa if you have ever had an allergic reaction to crisaborole or any of its ingredients — this is a contraindication.
  • Pregnancy: There is very limited human data on Eucrisa use during pregnancy. Animal studies at high oral doses showed some risks, but at lower doses there were no fetal problems. Talk to your doctor about the benefits and risks if you are pregnant or trying to conceive.
  • Breastfeeding: It is not known if crisaborole passes into breast milk. Discuss with your doctor whether to continue breastfeeding while using Eucrisa.
  • Infants under 3 months: The safety and effectiveness of Eucrisa have not been established in babies younger than 3 months old.
  • Older adults (65+): Clinical trials did not include enough older adults to know if they respond differently — your doctor will consider this when prescribing.
📡Pharmacodynamics — effects in the body

At the doses applied to the skin, Eucrisa ointment is not expected to affect your heart's electrical rhythm (specifically, it is not expected to prolong the QTc interval — a measure of heart electrical timing) to any clinically meaningful degree.

🔬Pharmacokinetics — how your body processes it

Even though crisaborole is applied to the skin, some of it is absorbed into the bloodstream. Studies in children showed measurable blood levels of the medicine, and it reaches a stable level in the body by about 8 days of regular use. Crisaborole is highly bound to proteins in the blood (about 97%) and is broken down in the body into inactive metabolites. These breakdown products are mainly cleared through the kidneys in urine.

📦How to store it

Store at 20°C–25°C (68°F–77°F); excursions permitted to 15°C–30°C (59°F–86°F).

📄 Written from Crisaborole Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

3

Supplements & herbs that interact with Crisaborole Topical

3 supplements and herbal products have documented interactions with Crisaborole Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 2
  • Minor · 1
Every supplement checked against Crisaborole Topical — ranked by severity The full interaction hub: 2 moderate · 1 minor · every one linked to its full report. Check Crisaborole Topical against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Crisaborole Topical — the kind of thing our pharmacy team would talk through with you at the counter.

What is Eucrisa actually for — is it just a fancy moisturizer?
No, it's a prescription medicine, not a moisturizer. Eucrisa contains crisaborole, which works by blocking an inflammatory enzyme in the skin. It's specifically approved to treat mild to moderate atopic dermatitis — eczema — in adults and kids as young as 3 months old. It won't replace your moisturizer, but it does something a moisturizer can't: it actively targets the inflammation driving your eczema.
It burns when I apply it — is that normal? Should I stop using it?
A burning or stinging sensation right after applying is actually the most commonly reported side effect — about 4% of people in clinical trials experienced it. For most people it's brief and fades. That said, if you notice severe itching, significant swelling, or spreading redness — especially beyond where you applied it — that could be an allergic reaction. Stop using it right away and contact your doctor or seek care if that happens.
How often do I apply it, and can I put it anywhere on my body?
You apply a thin layer to the affected areas of skin twice a day. Once your skin improves, your doctor may have you cut back to once a day. One important rule: keep it away from your eyes, mouth, and vaginal area — it's strictly for skin use only. Always follow exactly what your prescriber has told you.
Is it safe to use on my baby or young child?
Eucrisa is approved for children 3 months of age and older, and there is clinical trial data supporting its safety and effectiveness in kids from that age up through 17 years. It has not been studied in babies younger than 3 months, so it's not recommended for that age group. If you have any concerns about using it on a very young child, your pediatrician or prescriber is the best person to talk to.
I'm breastfeeding — is this safe to use?
There's no solid data yet on whether crisaborole passes into breast milk or what effect it could have on a nursing baby. Eucrisa is absorbed through the skin into the bloodstream to some extent, so it's a real question worth raising with your doctor. Your doctor can help you weigh the benefits of treating your eczema against any potential unknowns, and they may have guidance on where on your body to apply it to minimize any exposure to your baby.
Will Eucrisa interact with any of my other medications?
Based on lab studies, crisaborole is not expected to cause meaningful interactions with most medications at the skin doses normally used. A clinical study with warfarin — a common blood thinner — showed no interaction. If you're on a lot of medications, it's always a good idea to mention Eucrisa to your pharmacist, but significant drug interactions are not a major concern with this topical medicine.
Is Crisaborole Topical available over the counter?
Crisaborole Topical is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Crisaborole Topical first available?
Crisaborole Topical has been available in the United States since at least 2016, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Crisaborole Topical?
Crisaborole Topical is supplied by 2 manufacturers listed in the FDA NDC Directory, including Pfizer Laboratories Div Pfizer Inc, Pharmacia and Upjohn Company LLC.

💬 Answers drafted from Crisaborole Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Crisaborole Topical comes

Crisaborole Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

By mouth · On the skin
Brands Eucrisa
How this form is used
What it may be used for
  • Eucrisa is used to treat mild to moderate atopic dermatitis (eczema) in adults and children 3 months of age and older.
Important instructions
  • Eucrisa: apply a thin layer to the affected skin areas twice daily.
  • Eucrisa: once the skin improves, your prescriber may reduce application to once daily.
  • Eucrisa: for skin use only — do not apply to the eyes, mouth, or vaginal area.
  • Eucrisa: follow your prescriber's guidance on how much to use and for how long.
Available strengths 1 strength
4 FDA-listed product records

📊 Crisaborole Topical across the U.S. market

How Crisaborole Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
2
Manufacturers
1
Brand names
4
FDA-listed product records
2016
First marketed
Pfizer Laboratories Div Pfizer Inc75%
Pharmacia and Upjohn Company LLC25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Crisaborole Topical is used

A general measure of how commonly Crisaborole Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Crisaborole Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

80,367
Medicaid prescriptions filled (Q1–Q4 2025)
$64.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Crisaborole Topical prescribed? Of the 1,596 medications we measure, Crisaborole Topical ranks #545 by Medicaid prescriptions — more than 66% of them.

Where Crisaborole Topical ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Crisaborole Topical product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

crisaborole 0.02 MG/MG Topical Ointment

80,367 Medicaid prescriptions (Q1–Q4 2025) 100% of Crisaborole Topical prescriptions shown $64.8M gross reimbursement (before rebates) ≈ $807 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1865957

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Crisaborole Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 4 listed Crisaborole Topical NDCs with Medicaid activity.

🔍 Compare Crisaborole Topical products

A representative set of FDA-listed product records for Crisaborole Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Topical cream, ointment or gel
20 mg/g Topical Pfizer Laboratories Div Pfizer Inc × 3 listings NDA View NDC →
20 mg/g Pharmacia and Upjohn Company LLC DRUG FOR FURTHER PROCESSING View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Crisaborole Topical NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Crisaborole Topical RxCUI 1865953 1 dose form · 1 strength
  1. Dose form (SCDF) Topical Ointment RxCUI 1865956 In current FDA listings
    Clinical drug / strength (SCD) 0.02 MG/MG RxCUI 1865957

Look up RxCUI 1865953 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Eucrisa

🏭 Manufacturers & labelers

Pfizer Laboratories Div Pfizer Inc 3 Pharmacia and Upjohn Company LLC 1

RxNorm drug class

Crisaborole Topical belongs to the Phosphodiesterase 4 Inhibitor class.

Pharmacologic class Phosphodiesterase 4 Inhibitor
Drug family (ATC) Agents for dermatitis, excluding corticosteroids
How it works Phosphodiesterase 4 Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 23, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Crisaborole Topical.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Crisaborole Topical after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
2
Linked representative label
Pfizer Laboratories Div Pfizer Inc
Linked label effective
Sep 23, 2025
Composite sections available
20
Linked SPL Set ID
609b77de-1ca3-4783-b8f5-01a9c0f1d77d
Linked SPL Document ID
e5457495-d465-4c0a-a1ea-603c4c5823fb
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Pfizer Laboratories Div Pfizer Inc is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.