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FDA Approval

pramosone

CompanySebela Pharmaceuticals Inc. (DUNS: 079104574)

Effective Date

December 15, 2017

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocortisone acetate(10 mg in 1 g)

Hydrocortisone Acetate/Pramoxine Hydrochloride(10 mg in 1 g)

Manufacturing Establishments (1)

Ferndale Laboratories, Inc.

Labeler

Sebela Pharmaceuticals Inc.

DUNS Number

005320536

Products (1)

pramosone

NDC Product Code

54766-763

Route of Administration

TOPICAL

Effective Date

December 15, 2017

Ingredients

Hydrocortisone acetateActive

Code: 3X7931PO74Class: ACTIBQuantity: 10 mg in 1 g

WATERInactive

Code: 059QF0KO0RClass: IACT

PETROLATUMInactive

Code: 4T6H12BN9UClass: IACT

SORBITAN SESQUIOLEATEInactive

Code: 0W8RRI5W5AClass: IACT

Hydrocortisone Acetate/Pramoxine HydrochlorideActive

Code: 88AYB867L5Class: ACTIBQuantity: 10 mg in 1 g

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