FDA label 1da15065-b1bd-4774-97de-0e260a4556dc
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- SPL set ID
- 11054e55-9dd4-493f-8d1b-d6da7dad7ba2
- SPL ID
- 1da15065-b1bd-4774-97de-0e260a4556dc
- Version
- 1
- Effective date
- 2011-07-19
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:47:32
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 1da15065-b1bd-4774-97de-0e260a4556dc | id | |
| spl set id | 11054e55-9dd4-493f-8d1b-d6da7dad7ba2 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNING FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING AND IMMEDIATELY FOLLOWING APPLICATION. Keep out of reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperatures above 120ºF (49ºC). STIEFEL ® Manufactured for Stiefel Laboratories, Inc., a GlaxoSmithKline company RTP, NC 27709 USA PRASCO ® Distributed by Prasco Laboratories Mason, OH 45040 USA October 2009 304031 P/N: 129168 ©2009 Stiefel Laboratories, Inc., a GlaxoSmithKline company Printed in: US October 2009 Relabeling "Additional barcode label" by: Physicians Total Care, Inc. Tulsa, OK 74146
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS In a controlled pharmacokinetic study, 5 of 13 subjects experienced reversible suppression of the adrenals at any time during the 14 days of clobetasol propionate foam, 0.05% therapy to at least 20% of the body surface area. Of the 13 subjects studied, 1 of 9 with psoriasis were suppressed after 14 days and all 4 of the subjects with atopic dermatitis had abnormal cortisol levels indicative of adrenal suppression at some time after starting therapy with clobetasol propionate foam, 0.05%. See Table 3 below. Table 3: Subjects with reversible HPA axis suppression at any time during treatment Dermatosis Clobetasol Propionate Foam, 0.05% Psoriasis 1 of 9 Atopic Dermatitis 4 of 4 Systemic absorption of topical corticosteroids has produced reversible adrenal suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. See PRECAUTIONS . In a controlled clinical trial (188 subjects) with clobetasol propionate foam, 0.05% in subjects with psoriasis of the scalp, there were no localized scalp adverse reactions reported in the clobetasol propionate foam, 0.05% treated subjects. In two controlled clinical trials (360 subjects) with clobetasol propionate foam, 0.05% in subjects with psoriasis of non-scalp regions, localized adverse events that occurred in the clobetasol propionate foam, 0.05% treated subjects included application site burning (10%), application site dryness (<1%), and other application site reactions (4%). In larger controlled trials with other clobetasol propionate formulations, the most frequently reported local adverse reactions have included burning, stinging, irritation, pruritus, erythema, folliculitis, cracking and fissuring of the skin, numbness of the fingers, skin atrophy, and telangiectasia (all less than 2%). The following additional local adverse reactions have been reported with topical corticosteroids, but they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids such as clobetasol propionate foam, 0.05%. These reactions are listed in an approximate decreasing order of occurrence: dryness, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, striae, and miliaria.
adverse reactions table
<table border="single" width="413.000" ID="id_6878b532-10ad-47a2-b78e-8f4380e1bd68"> <caption ID="id_e77104d1-f0e4-4c03-9064-cfbe4083b75e">Table 3: Subjects with reversible HPA axis suppression at any time during treatment</caption> <col width="49.4%"/> <col width="50.6%"/> <tbody> <tr ID="id_8189c696-150b-4e00-b474-32f4c7ffc8dd"> <td align="left" valign="top" styleCode="Botrule Toprule Rrule Lrule">Dermatosis</td> <td align="center" valign="top" styleCode="Botrule Rrule">Clobetasol Propionate Foam, 0.05%</td> </tr> <tr ID="id_015ff557-699e-404c-bbc8-f5fb235eb484"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Psoriasis</td> <td align="center" valign="top" styleCode="Botrule Rrule">1 of 9</td> </tr> <tr ID="id_adc4b9ea-7172-42a6-9181-51257f449e94"> <td align="left" valign="top" styleCode="Lrule Botrule Rrule">Atopic Dermatitis </td> <td align="center" valign="top" styleCode="Botrule Rrule">4 of 4</td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.