Nyclobate

For external use only. Apply a thin layer to the affected skin and rub in gently. Wash hands after application. Avoid contact with eyes, mouth, and other mucous membranes. Do not use on the face, groin, or axillae, or for diaper dermatitis unless directed by a physician.

Clobetasol Propionate is a topical corticosteroid that acts as an anti-inflammatory, anti-pruritic, and vasoconstrictive agent. It induces phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

• Hypersensitivity to Clobetasol Propionate or any components of the formulation.
• Rosacea, acne vulgaris, perioral dermatitis.
• Pruritus without inflammation.
• Perianal and genital pruritus.
• Primary cutaneous viral infections (e.g., herpes simplex, chickenpox).
• Fungal or bacterial skin infections (unless concurrent appropriate anti-infective therapy is used).
• Tuberculosis of the skin.

Store below 30°C. Protect from light and moisture. Keep out of reach of children.

Topically applied Nyclobate 0.05% Lotion can be absorbed in sufficient amounts to produce systemic effects, including adrenal suppression. If HPA axis suppression is noted, withdraw the drug gradually, reduce the frequency of application, or substitute with a less potent corticosteroid.

Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution in nursing mothers. Consult a physician.

• Hypersensitivity to Clobetasol Propionate or any components of the formulation.
• Rosacea, acne vulgaris, perioral dermatitis.
• Pruritus without inflammation.
• Perianal and genital pruritus.
• Primary cutaneous viral infections (e.g., herpes simplex, chickenpox).
• Fungal or bacterial skin infections (unless concurrent appropriate anti-infective therapy is used).
• Tuberculosis of the skin.

Store below 30°C. Protect from light and moisture. Keep out of reach of children.

Topically applied Nyclobate 0.05% Lotion can be absorbed in sufficient amounts to produce systemic effects, including adrenal suppression. If HPA axis suppression is noted, withdraw the drug gradually, reduce the frequency of application, or substitute with a less potent corticosteroid.

Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution in nursing mothers. Consult a physician.