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Temovate 0.05% Ointment 30 Gm By Pharmaderm Brand

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Temovate 0.05% Ointment 30 Gm By Pharmaderm Brand

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Temovate 0.05% Ointment 30 Gm By Pharmaderm Brand This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10106583/RXD4603973/RXA391065
Size : 30 GM
Selling UoM : EA
NDC: 10337-0162-30
UPC Barcode : 310337162303
Supplier: 0050001556 PHARMADERM BRANDED
Supplier Material : 016230
Generic Code : 007635 CLOBETASOL PROPIONATE TOPICAL OINT. (G)
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Bra

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Product Description.:

Ointment , off-white

TEMOVATE?
(clobetasol propionate ointment) Ointment, 0.05%

FOR TOPICAL DERMATOLOGIC USE ONLY-
NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE

DESCRIPTION
TEMOVATE (clobetasol propionate cream and ointment) Cream and Ointment contain the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Ciobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity.

Clobetasol propionate has the empirical formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water.

TEMOVATE Cream contains clobetasol propionate 0.5 mg/g in a cream base of propylene glycol, glyceryl monostearate, cetostearyl alcohol, glyceryl stearate, PEG 100 stearale, white wax, chlorocresol, sodium citrate, citric acid monohydrate, and purified water.

TEMOVATE Ointment contains clobetasol propionate 0.5 mg/g in a base of propylene glycol, sorbitan sesquioleate, and white petrolatum.

INDICATIONS

TEMOVATE Cream and Ointment are super-high potency corticosteroid formulations indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g/week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended.

As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.

SIDE EFFECTS

In controlled clinical trials, the most frequent adverse reactions reported for TEMOVATE Cream were burning and stinging sensation in 1% of treated patients. Less frequent adverse reactions were itching, skin atrophy, and cracking and Assuring of the skin.

In controlled clinical trials, the most frequent adverse events reported for TEMOVATE Ointment were burning sensation,.irritation, and itching in 0.5% of treated patients. Less frequent adverse reactions were stinging, cracking, erythema, folliculitis, numbness of fingers, skin atrophy, and telangiectasia.

Cushing's syndrome has been reported in infants and adults as a result of prolonged use of topical clobetasol propionate formulations.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, irritation, striae, and miliaria.

OVERDOSE

Topically applied TEMOVATE Cream and Ointment can be absorbed in sufficient amounts to produce systemic effects

CONTRAINDICATIONS

TEMOVATE Cream and Ointment are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.