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FDA Approval

HYDROCORTISONE 2.5% / KETOCONAZOLE 2%

CompanySincerus Florida, LLC (DUNS: 080105003)

Effective Date

May 16, 2019

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocortisone(2.5 g in 100 g)

Ketoconazole(2 g in 100 g)

Manufacturing Establishments (1)

Sincerus FLorida, LLC

Labeler

Sincerus Florida, LLC

DUNS Number

080105003

Products (1)

HYDROCORTISONE 2.5% / KETOCONAZOLE 2%

NDC Product Code

72934-2112

Route of Administration

TOPICAL

Effective Date

May 16, 2019

Ingredients

HydrocortisoneActive

Code: WI4X0X7BPJClass: ACTIBQuantity: 2.5 g in 100 g

KetoconazoleActive

Code: R9400W927IClass: ACTIBQuantity: 2 g in 100 g

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