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Rx Item-Desoximetasone 0.25% Ont 60Gm By Fougera Pharma

NDC 00168-0151-60 UPC/GTIN No.3-01680-15160-1 Mfg.Part No.15160BRAND: DESOXIMETASONE NDC: 00168-0151-60,168015160 UPC: 3-01680-15160-1,301680151601 Fougera E And Co IncOnly 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 scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Desoximetasone 0.25% Ont 60Gm By Fougera Pharma

$294.54$280.51

Item No.:RX365092 NDC No.168015160 UPC No.:301680151601 NDC No. 00168-0151-60 UPC/GTIN No. 3-01680-15160-1 MPN 15160 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx365092 Desoximetasone 0.25% Ont 60gm by Fougera Pharma Item No. 3365092 NDC No. 00168015160 UPC No. 301680151601 Other Name Topicort

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TOPICORT- desoximetasone cream
TOPICORT- desoximetasone gel
Taro Pharmaceuticals U.S.A., Inc.

For topical use only. Not for oral, ophthalmic, or intravaginal use.

Rx only

DESCRIPTION

Topicort� (desoximetasone cream USP) 0.05%, Topicort� (desoximetasone cream USP) 0.25%, and Topicort� (desoximetasone gel USP) 0.05% contain the active synthetic corticosteroid desoximetasone. The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents.



Each gram of Topicort� (desoximetasone cream USP) 0.05% contains 0.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, edetate disodium, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum.

Each gram of Topicort� (desoximetasone cream USP) 0.25% contains 2.5 mg of desoximetasone in an emollient cream base consisting of cetostearyl alcohol, isopropyl myristate, lanolin alcohol, mineral oil, purified water, and white petrolatum.

Each gram of Topicort� (desoximetasone gel USP) 0.05% contains 0.5 mg of desoximetasone in a gel base consisting of carbomer 940, docusate sodium, edetate disodium, isopropyl myristate, purified water, SDAG-3 95% alcohol, and trolamine.

The chemical name of desoximetasone is Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 21-dihydroxy-16-methyl-,(11?,16?)-.

Desoximetasone has the molecular formula C22 H29 FO4 and a molecular weight of 376.47. The CAS Registry Number is 382-67-2.
CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.
Topicort Indications and Usage

Topicort� (desoximetasone cream USP) 0.05%, Topicort� (desoximetasone cream USP) 0.25%, and Topicort� (desoximetasone gel USP) 0.05% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

Topicort� (desoximetasone cream USP) 0.05%, Topicort� (desoximetasone cream USP) 0.25%, and Topicort� (desoximetasone gel USP) 0.05% are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS

Keep out of reach of children.

PRECAUTIONS

General
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid.

Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure.

An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids.

Cushing�s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids.

Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure.

Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids.
Information for the Patient
Patients using topical corticosteroids should receive the following information 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 that for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
Patients should report any signs of local adverse reactions, especially under occlusive dressings.
Other corticosteroid-containing products should not be used with Topicort� (desoximetasone cream USP) 0.05%, Topicort� (desoximetasone cream USP) 0.25%, or Topicort� (desoximetasone gel USP) 0.05% without first consulting with the physician.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 4 weeks, contact the physician.

Laboratory Tests
The following tests may be helpful in evaluating the hypothalamic-pituitary-adrenal (HPA) axis suppression:

Urinary free cortisol test
ACTH stimulation test
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Desoximetasone was nonmutagenic in the Ames test.

Pregnancy
Teratogenic Effects
Pregnancy Category C
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals.
OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin film of Topicort� (desoximetasone cream USP) 0.05%, Topicort� (desoximetasone cream USP) 0.25%, or Topicort� (desoximetasone gel USP) 0.05% to the affected skin areas twice daily. Rub in gently.

NDC 00168-0151-60 UPC/GTIN No.3-01680-15160-1 Mfg.Part No.15160
RX ITEM-Desoximetasone 0.25% Ont 60Gm By
NDC 00168-0151-60 UPC/GTIN No.3-01680-15160-1 Mfg.Part No.15160

BRAND: DESOXIMETASONE NDC: 00168-0151-60,168015160 UPC: 3-01680-15160-1,301680151601 Fougera E And Co Inc
Desoximetasone 0.25% Ont 60Gm By Fougera
BRAND: DESOXIMETASONE NDC: 00168-0151-60,168015160 UPC: 3-01680-15160-1,301680151601 Fougera E And Co Inc

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
DESOXIMETASONE TOPICAL OI
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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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.