Synalar

FLUOCINOLONE ACETONIDE TOPICAL HUMAN PRESCRIPTION DRUG

Synalar is an FDA drug label for the active ingredient FLUOCINOLONE ACETONIDE manufactured by Medimetriks Pharmaceuticals, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231129.

Generic name
FLUOCINOLONE ACETONIDE
Manufacturer
Medimetriks Pharmaceuticals, Inc.
Product type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Dosage form
N/A
NDC
43538-910
Application
NDA013960
Label effective
20231129

Indications & Usage

INDICATIONS AND USAGE SYNALAR ® Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.

Dosage & Administration

DOSAGE AND ADMINISTRATION SYNALAR ® Ointment is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. Some plastic films may be flammable and due care should be exercised in their use. Similarly, caution should be employed when such films are used on children or left in their proximity, to avoid the possibility of accidental suffocation. If an infection develops, the use of the occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Contraindications

CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Warnings

Not available.

Adverse Reactions

ADVERSE REACTIONS 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: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria

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