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FDA Approval

CORTANE-B

CompanyBLANSETT PHARMACAL CO (DUNS: 037477378)

Effective Date

March 20, 2017

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocortisone(10 mg in 1 mL)

Chloroxylenol(1 mg in 1 mL)

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

Manufacturing Establishments (1)

BLANSETT PHARMACAL CO

Labeler

BLANSETT PHARMACAL CO

DUNS Number

037477378

Products (1)

CORTANE-B

NDC Product Code

51674-0117

Route of Administration

TOPICAL

Effective Date

March 20, 2017

Ingredients

HydrocortisoneActive

Code: WI4X0X7BPJClass: ACTIBQuantity: 10 mg in 1 mL

ChloroxylenolActive

Code: 0F32U78V2QClass: ACTIBQuantity: 1 mg in 1 mL

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

Hydrocortisone Acetate/Pramoxine HydrochlorideActive

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

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