FDA Label for Cordran
View Indications, Usage & Precautions
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- ADVERSE REACTIONS
- POSTMARKETING ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- OTHER
- PRINCIPAL DISPLAY PANEL - 60 G TUBE - 0.05%
- PRINCIPAL DISPLAY PANEL - 60 G TUBE CARTON - 0.05%
- PRINCIPAL DISPLAY PANEL - 120 G TUBE - 0.05%
- PRINCIPAL DISPLAY PANEL - 120 G TUBE CARTON - 0.05%
Cordran Product Label
The following document was submitted to the FDA by the labeler of this product Almirall, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Cordran® (flurandrenolide, USP) is a potent corticosteroid intended 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 of flurandrenolide 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, 11β, 16α)-; its empirical formula is C24H33FO6. The structure is as follows:
Each gram of Cordran® Cream (flurandrenolide Cream, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in an emulsified base composed of cetyl alcohol, citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate, stearic acid, and purified water.
Each gram of Cordran® Ointment (flurandrenolide Ointment, USP) contains 0.5 mg (1.145 µmol; 0.05%) or 0.25 mg (0.57 µmol; 0.025%) flurandrenolide in a base composed of white wax, cetyl alcohol, sorbitan sesquioleate, and white petrolatum.
Clinical Pharmacology
Cordran is primarily effective because of its anti-inflammatory, antipruritic, and vasoconstrictive actions.
The mechanism of the anti-inflammatory effect of topical corticosteroids is not completely understood. Corticosteroids with anti-inflammatory activity may stabilize cellular and lysosomal membranes. There is also the suggestion that the effect on the membranes of lysosomes prevents the release of proteolytic enzymes and, thus, plays a part in reducing inflammation.
Indications And Usage
Cordran® (flurandrenolide, USP) is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Contraindications
Topical corticosteroids are contraindicated in patients with a history of hypersensitivity to any of the components of these preparations.
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:
The following may occur more frequently with occlusive dressings:
Postmarketing Adverse Reactions
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.
Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).
Dosage And Administration
For moist lesions, a small quantity of the cream should be rubbed gently into the affected areas 2 or 3 times a day. 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.
Cordran® (flurandrenolide, USP) should not be used with occlusive dressings unless directed by a physician. Tight-fitting diapers or plastic pants may constitute occlusive dressings.
How Supplied
Cordran® Cream is supplied in aluminum tubes as follows:
| Cordran® Cream, 0.025%: | |
| 30 g | (NDC 16110-034-30) |
| 60 g | (NDC 16110-034-60) |
| 120 g | (NDC 16110-034-12) |
| Cordran® Cream, 0.05%: | |
| 15 g | (NDC 16110-035-15) |
| 30 g | (NDC 16110-035-30) |
| 60 g | (NDC 16110-035-60) |
| 120 g | (NDC 16110-035-12) |
Cordran® Ointment is supplied in aluminum tube as follows:
| Cordran® Ointment, 0.05%: | |
| 15 g | (NDC 16110-026-15) |
| 30 g | (NDC 16110-026-30) |
| 60 g | (NDC 16110-026-60) |
Storage And Handling
Keep out of reach of children.
Storage
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.].
Other
Rx Only
Revision: 08/2013
Manufactured by DPT Laboratories, San Antonio, TX 78215
For Aqua Pharmaceuticals, West Chester, PA 19380
140165
Principal Display Panel - 60 G Tube - 0.05%
60 g Tube
NDC 16110-035-60
Cordran®
Flurandrenolide Cream, USP
0.05% Rx Only
FOR EXTERNAL USE ONLY - NOT FOR USE IN THE EYES
USUAL DOSAGE: Apply to affected area 2 or 3 times a day. See package insert.
Each gram contains: flurandrenolide 0.5 mg (0.05%), cetyl alcohol,
citric acid, mineral oil, polyoxyl 40 stearate, propylene glycol, sodium citrate,
stearic acid and purified water.
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].
Keep Tightly Closed and Protect from Light.
IMPORTANT: Do not use if seal has been punctured or is not visible.
Cap is Not Child Resistant. Keep Away from Children.
See Crimp for Expiration Date and Lot No.
Manufactured by DPT Laboratories, San Antonio, TX 78215
For Aqua Phamraceuticals, West Chester, PA 19380
60 g Tube
NDC 16110-026-60
Cordran®
Flurandrenolide Ointment, USP
0.05% Rx Only
FOR EXTERNAL USE ONLY - NOT FOR USE IN THE EYES
USUAL DOSAGE: Apply to affected area 2 or 3 times a day. See package insert.
Each gram contains: flurandrenolide 0.5 mg (0.05%), white wax, cetyl alcohol,
sorbitan sesquioleate and white petrolatum.
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].
Keep Tightly Closed and Protect from Light.
IMPORTANT: Do not use if seal has been punctured or is not visible.
Cap is Not Child Resistant. Keep Away from Children.
See Crimp for Expiration Date and Lot No.
Manufactured by DPT Laboratories, San Antonio, TX 78215
For Aqua Phamraceuticals, West Chester, PA 19380
Principal Display Panel - 60 G Tube Carton - 0.05%
60 g Tube
NDC 16110-035-60
Cordran®
Flurandrenolide Cream, USP
0.05% USUAL DOSAGE: Apply to affected area 2 or 3 times a day. Rx only
60 g Tube
NDC 16110-026-60
Cordran®
Flurandrenolide Ointment, USP
0.05% USUAL DOSAGE: Apply to affected area 2 or 3 times a day. Rx only
Principal Display Panel - 120 G Tube - 0.05%
120 g Tube
NDC 16110-035-12
Cordran®
Flurandrenolide Cream, USP
0.05% Rx Only
FOR EXTERNAL USE ONLY -
NOT FOR USE IN THE EYES
USUAL DOSAGE: Apply to affected area
2 or 3 times a day. See package insert.
Each gram contains:
flurandrenolide 0.5 mg (0.05%),
cetyl alcohol, citric acid, mineral oil,
polyoxyl 40 stearate, propylene glycol,
sodium citrate, stearic acid and purified water.
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].
Keep Tightly Closed and Protect from Light.
IMPORTANT: Do not use if seal has been punctured or is not visible.
Cap is Not Child Resistant.
Keep Away from Children.
See Crimp for Expiration Date and Lot No.
Manufactured by DPT Laboratories, San Antonio, TX 78215
For Aqua Phamraceuticals, West Chester, PA 19380
Principal Display Panel - 120 G Tube Carton - 0.05%
120 g Tube
NDC 16110-035-12
Cordran®
Flurandrenolide Cream, USP
0.05% USUAL DOSAGE: Apply to affected area 2 or 3 times a day. Rx only
* Please review the disclaimer below.
