FDA label ef1d39a8-99b2-d39f-e053-2995a90a2afa

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 (canonical bytes are SHA-256 checked before publication)

SPL set ID
81a55188-1f73-c212-e053-2991aa0a0719
SPL ID
ef1d39a8-99b2-d39f-e053-2995a90a2afa
Version
6
Effective date
2022-12-05
Source export date
2026-08-01
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/5cbbf4af8f4e275ec50931155b30ffa7322568b9af8a1c936a47f6d6774862fd/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:02:32

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Use of topical corticosteroids, including diflorasone diactate dintment may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts have been reported in postmarketing experience with the use of topical diflorasone diacetate products. Glaucoma, with possible damage to the optic nerve, and increased intraocular pressure have been reported in postmarketing experience with the use of topical dermal corticosteroids. Avoid contact of Diflorasone Diacetate Ointment with eyes. Advise patients to report any visual symptoms.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

Adverse Reactions The following local adverse reactions have been identified from clinical trials or postmarketing surveillance. Because they are reported from a population from unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to topical corticosteroids exposure. These adverse reactions may occur more frequently with the use of occlusive dressings or prolonged use of topical corticosteroids. Skin and Subcutaneous Tissue Disorders : burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria. Vision Disorders: cataract, glaucoma, central serous chorioretinopathy To report SUSPECTED ADVERSE REACTIONS , contact Teligent Pharma, Inc. at 1-856-697-1441, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.