Clobetasol Gel

Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours has not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Greater absorption was observed for the clobetasol propionate gel formulation as compared to the cream formulation in in vitro human skin penetration studies. Studies performed with clobetasol propionate gel indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

Clobetasol propionate gel, 0.05% is a super-high potency corticosteroid formulation 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 per 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.

Clobetasol propionate gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Clobetasol Propionate Gel, 0.05% is supplied in tamper-evident tubes as follows:

15 gram (NDC: 52565-082-15)
30 gram (NDC: 52565-082-30)
60 gram (NDC: 52565-082-60)

Store at controlled room temperature 15°-30°C (59°-86°F). DO NOT REFRIGERATE.

Manufactured by:
Teligent Pharma, Inc.
Buena, NJ 08310

Revised 03/2017 

NDC 52565-082-15

Teligent Pharma, Inc.                    

CLOBETASOL PROPIONATE GEL, 0.05%

Rx only

FOR DERMATOLOGIC USE ONLY

NOT FOR OPHTHALMIC USE

NET WT 15 grams