Rx Item-Apexicon E diflorasone diacetate 0.05% Cream 60gm by Pharmaderm

Clinical Information
Gen. Code and Des.
41729 diflorasone diacet/emollient TOPICAL CREAM (G) 0.05 %
GCN and Des.
67730 diflorasone diacet/emollient TOPICAL CREAM (G) 0.05 %
Strength
0.05%
Dose Form
CREAM (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE)
Active Ingredients
2201 diflorasone diacetate 33564317
2446 emollient base
Inactive Ingredients
2468 propylene glycol 57556
7543 sorbitan esters

APEXICON- diflorasone diacetate ointment
Pharmaderm, division of Nycomed US Inc.
FOR EXTERNAL USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
ApexiCon? Ointment (diflorasone diacetate ointment USP 0.05%) contains 0.5 mg diflorasone diacetate in an ointment base.
Chemically, diflorasone diacetate is 6?,9-difluoro-11?,17,21-trihydroxy-16?-methylpregna-1,4-diene-3,20-dione 17,21- diacetate with the molecular formula C26 H32 F2 O7 and molecular weight of 494.54
Each gram of ApexiCon? Ointment (diflorasone diacetate ointment USP 0.05%), for topical administration, contains 0.5 mg diflorasone diacetate in an ointment base consisting of propylene glycol, glyceryl monostearate and white petrolatum.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.
INDICATIONS AND USAGE
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS
Topical steroids are contraindicated in those patients with history of hypersensitivity to any of the components of the preparation.
PRECAUTIONS
General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing?s syndrome, hyperglycemia, and glucosuria in some patients.
info. for Patients: Patients using topical corticosteroids should receive the following info. and instructions:
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
Patients should report any signs of local adverse reactions especially under occlusive dressing.
Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on child being treated in the diaper area, as these garments may constitute occlusive dressings.
Pregnancy: Teratogenic effects? Pregnancy Category C
DOSAGE AND ADMINISTRATION
ApexiCon? Ointment (diflorasone diacetate ointment USP 0.05%) should be applied to the affected area as thin film from one to three times daily depending on the severity or resistant nature of the condition.
Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.
If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.

Apexicon E 0.05% Cream 60gm by Pharmader
NDC No.10337-0395-60 UPC/GTIN No.3-10337-39560-2 MPN 39560 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapis

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DIFLORASONE DIACETATE/EMO
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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