CORDRAN FLURANDRENOLIDE ALMIRALL, LLC FDA Approved Cordran Tape (Flurandrenolide Tape, USP) is a transparent, inconspicuous, plastic surgical tape. It contains Cordran (Flurandrenolide, USP), a potent corticosteroid for topical use. Flurandrenolide occurs as white to off-white, fluffy crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21 dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11ß, 16α)-; its empirical formula is C 24 H 33 FO 6 . The structural formula is as follows: Each square centimeter contains 4 mcg (0.00916 μmol) flurandrenolide uniformly distributed in the adhesive layer. The tape is made of a thin, matte-finish polyethylene film that is slightly elastic and highly flexible. The adhesive is a synthetic copolymer of acrylate ester and acrylic acid that is free from substances of plant origin. The pressure-sensitive adhesive surface is covered with a protective paper liner to permit handling and trimming before application. Chemical Structure
Generic: FLURANDRENOLIDE
Mfr: ALMIRALL, LLC FDA Rx Only
FunFoxMeds bottle
Substance Flurandrenolide
Route
TOPICAL
Applications
NDA016455

Drug Facts

Composition & Profile

Strengths
4 mcg
Quantities
24 count
Treats Conditions
Indications And Usage For Relief Of The Inflammatory And Pruritic Manifestations Of Corticosteroid Responsive Dermatoses Particularly Dry Scaling Localized Lesions

Identifiers & Packaging

Container Type BOTTLE
UNII
8EUL29XUQT
Packaging

HOW SUPPLIED Tape: 4 mcg/sq cm—small roll, 24 in x 3 in (60 cm x 7.5 cm), in a flip-top vial NDC 16110-587-24 4 mcg/sq cm—large roll, 80 in x 3 in (200 cm x 7.5 cm), in a flip-top vial NDC 16110-587-80 Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep out of reach of children. Rx only; PRINCIPAL DISPLAY PANEL - NDC: 16110-587-80 - Carton Label carton label; PRINCIPAL DISPLAY PANEL - NDC: 16110-587-80 - Vial Label vial label

Package Descriptions
  • HOW SUPPLIED Tape: 4 mcg/sq cm—small roll, 24 in x 3 in (60 cm x 7.5 cm), in a flip-top vial NDC 16110-587-24 4 mcg/sq cm—large roll, 80 in x 3 in (200 cm x 7.5 cm), in a flip-top vial NDC 16110-587-80 Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep out of reach of children. Rx only
  • PRINCIPAL DISPLAY PANEL - NDC: 16110-587-80 - Carton Label carton label
  • PRINCIPAL DISPLAY PANEL - NDC: 16110-587-80 - Vial Label vial label

Overview

Cordran Tape (Flurandrenolide Tape, USP) is a transparent, inconspicuous, plastic surgical tape. It contains Cordran (Flurandrenolide, USP), a potent corticosteroid for topical use. Flurandrenolide occurs as white to off-white, fluffy crystalline powder and is odorless. Flurandrenolide is practically insoluble in water and in ether. One gram dissolves in 72 mL of alcohol and in 10 mL of chloroform. The molecular weight of flurandrenolide is 436.52. The chemical name of flurandrenolide is Pregn-4-ene-3,20-dione, 6-fluoro-11,21 dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11ß, 16α)-; its empirical formula is C 24 H 33 FO 6 . The structural formula is as follows: Each square centimeter contains 4 mcg (0.00916 μmol) flurandrenolide uniformly distributed in the adhesive layer. The tape is made of a thin, matte-finish polyethylene film that is slightly elastic and highly flexible. The adhesive is a synthetic copolymer of acrylate ester and acrylic acid that is free from substances of plant origin. The pressure-sensitive adhesive surface is covered with a protective paper liner to permit handling and trimming before application. Chemical Structure

Indications & Usage

For relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, particularly dry, scaling localized lesions.

Dosage & Administration

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of Cordran Tape and other occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted. Replacement of the tape every 12 hours produces the lowest incidence of adverse reactions, but it may be left in place for 24 hours if it is well tolerated and adheres satisfactorily. When necessary, the tape may be used at night only and removed during the day. If ends of the tape loosen prematurely, they may be trimmed off and replaced with fresh tape. The directions given below are included for the patient to follow unless otherwise instructed by the physician.

Warnings & Precautions
No warnings available yet.
Contraindications

Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations. Use of Cordran Tape is not recommended for lesions exuding serum or in intertriginous areas.

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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis. The following may occur more frequently with occlusive dressings: maceration of the skin, secondary infection, skin atrophy, striae, miliaria.


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