CORTANE-B- hydrocortisone, pramoxine hcl, chloroxylenol lotion

CORTANE-B by

Drug Labeling and Warnings

CORTANE-B by is a Prescription medication manufactured, distributed, or labeled by BLANSETT PHARMACAL CO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE AND ADMINISTRATION

APPLY TO THE AFFECTED AREA 3 TO 4 TIMES DAILY. SEE INSERT FOR COMPLETE INSTRUCTIONS.

SPL UNCLASSIFIED SECTION

EACH 1 ML CONTAINS:

HYDROCORTISONE   10 MG

PRAMOXINE HCL      10 MG

CHLOROXYLENOL      1 MG

IS A BLAND VEHICLE WITH BENZALKONIUM CHLORIDE AS A PRESERVATIVE.

WARNING:

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

OTHER SAFETY INFORMATION

PROTECT FROM FREEZING (SHAKE WELL)

NOT FOR OPTHALMIC USE.

STORE AT CONTROLLED ROOM TEMPARATURE 15°-30°C (50°-86°F).

PROTECT FROM LIGHT.

DISPENSE IN CONTAINER.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORTANE-B 
hydrocortisone, pramoxine hcl, chloroxylenol lotion

Product 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)