The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:
Allergic contact dermatitis
The following may occur more frequently with occlusive dressings:
Maceration of the skin
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.
The following adverse reactions have been identified during post approval use of flurandrenolide, USP. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin: skin striae, hypersensitivity, skin atrophy, contact dermatitis and skin discoloration.
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
For dry, scaly lesions, the ointment is applied as a thin film to affected areas 2 or 3 times daily.
Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Flurandrenolide ointment should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.
Flurandrenolide Ointment USP, 0.05% is available as follows:
|NDC 52565-017-15||15 gram tubes|
|NDC 52565-017-30||30 gram tubes|
|NDC 52565-017-60||60 gram tubes|
Keep out of reach of children.
Keep tightly closed.
Protect from light.
Store at 20° to 25°C (68° to 77°F) with excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]
Teligent Pharma, Inc.
Buena, New Jersey 08310
Ointment USP, 0.05%
Net Wt. 15 grams
For External Use Only
Not For Use In The Eyes
|FLURANDRENOLIDE flurandrenolide ointment|
|Labeler — Teligent Pharma, Inc. (011036910)|
|Registrant — Teligent Pharma, Inc. (011036910)|
|Teligent Pharma, Inc.||011036910||manufacture (52565-017)|
Revised: 12/2016 Teligent Pharma, Inc.
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