Label Changes for:

Clobex (clobetasol propionate) Spray, 0.05%

September 2012

Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – September 2012

 

PATIENT PACKAGE INSERT

"You should not use CLOBEX Spray"

  • It is not known if CLOBEX Spray is safe and effective in children under 18 years of age. CLOBEX Spray should not be used in children under 18 years of age.

"What are the possible side effects of CLOBEX Spray?"

  • "Too much Clobex spray passing through your skin can cause your adrenal glands to stop working. Your doctor may do blood tests to check how well your adrenal glands are working."

 

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