Label: CORTANE-B- hydrocortisone, pramoxine hcl, chloroxylenol lotion
-
Contains inactivated NDC Code(s)
NDC Code(s): 51674-0117-2 - Packager: BLANSETT PHARMACAL CO
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated March 20, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DOSAGE AND ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- WARNING:
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CORTANE-B
hydrocortisone, pramoxine hcl, chloroxylenol lotionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51674-0117 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 mL PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51674-0117-2 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/20/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/20/2017 Labeler - BLANSETT PHARMACAL CO (037477378) Establishment Name Address ID/FEI Business Operations BLANSETT PHARMACAL CO 037477378 manufacture(51674-0117)