Partial
Partially Aligned
Patient Risk:
Info
Summary
Most core indication/dosing-use statements match the provided label excerpts, but several efficacy/safety/side-effect and use-category assertions (e.g., itching/clinical goals, timing of improvement, flare-dependent control, and specific ADR wording) are not supported by the supplied label text.
Category Scores
Accurate Statements
Eucrisa (crisaborole) is a topical prescription medication for mild to moderate atopic dermatitis (eczema).
Label 1 INDICATIONS AND USAGE indicates topical treatment for mild to moderate atopic dermatitis.
Eucrisa is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older.
Label 1 INDICATIONS AND USAGE.
Eucrisa is used on affected areas.
Label 2 DOSAGE AND ADMINISTRATION: apply a thin layer to affected areas.
Eucrisa is typically applied twice daily to involved skin as directed by a clinician.
Label 2 DOSAGE AND ADMINISTRATION: apply thin layer twice daily.
Clinical labeling and study-based use information describe treatment for atopic dermatitis applied twice daily.
Label 2 DOSAGE AND ADMINISTRATION (twice daily) and clinical studies describe EUCRISA applied twice daily in trials.
Unsupported Statements
Eucrisa is used to treat skin inflammation associated with flare-ups of atopic dermatitis.
The supplied label excerpts include an indication for atopic dermatitis and trial descriptions, but do not explicitly state treatment of 'skin inflammation' or 'flare-ups' as wording supporting this claim.
Eucrisa is used to treat itching associated with flare-ups of atopic dermatitis.
No itching-related indication wording is present in the provided label excerpts.
Eucrisa is intended to reduce eczema symptoms such as itching.
No itching/symptom-reduction language is present in the provided label excerpts.
Eucrisa is intended to improve the look and feel of affected skin during flare activity.
No 'look and feel' or flare-activity intent is present in the provided label excerpts.
Eucrisa is prescribed for atopic dermatitis cases in the 'mild to moderate' category.
The label supports mild to moderate indication, but this phrasing is redundant and not adding label-supported detail beyond the indication; treated as not directly supported as stated.
Symptom improvement can begin after starting treatment.
The supplied excerpts do not describe onset timing of improvement.
Eczema control usually depends on consistent use during flare periods.
The supplied excerpts do not state that control 'usually depends' on consistent use during flare periods.
The most commonly reported side effects are application-site reactions.
The provided label excerpts include a section header for adverse reactions but do not supply adverse reaction content; thus this cannot be supported.
Application-site reactions with Eucrisa especially include burning or stinging at the area where Eucrisa is applied.
Specific adverse reaction details (burning/stinging) are not present in the supplied label excerpts.
Eucrisa is a non-steroid topical option for atopic dermatitis.
The supplied label excerpts do not state that Eucrisa is non-steroidal.
Contradictions
Important Omissions
Once clinical effect is achieved, consider reducing application to once daily [see Clinical Studies (14)].
Importance:
Moderate
Eucrisa is for topical use only and not for ophthalmic, oral, or intravaginal use.
Importance:
Moderate
Age limitation detail already present in indication (3 months of age and older), but no mention of adult/pediatric split beyond that age threshold; inclusion is partially covered but not fully reflected across all statements.
Importance:
Low
Safety Assessment
Potential Patient Risk:
Info
Most incorrect items are unsupported efficacy/side-effect characterizations rather than direct dosing contradictions; however, omissions of route limitations and once-daily reduction considerations could affect safe administration.
Regulatory Assessment
| On Label |
No |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Partially Aligned
Primary Issue
Several claims (itching/flare intent, onset timing, adverse reaction specifics, and non-steroid status) are not supported by the provided FDA label excerpts; also missing key administration safety details (topical-only/avoid ophthalmic-orald intravaginal) and once-daily reduction after clinical effect.
Suggested Improvement
Limit statements to label-supported indication and dosing from the provided excerpts (twice daily thin layer to affected areas; consider once-daily after clinical effect; topical use only not ophthalmic/oral/intravaginal). Remove or qualify unsupported efficacy/safety claims (itching, flare activity, onset timing, common side effect wording, burning/stinging, and non-steroid characterization) unless additional label text is provided.