CORTANE-B- hydrocortisone, pramoxine hcl, chloroxylenol lotion
BLANSETT PHARMACAL CO

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.

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CORTANE-B LOTION

DOSAGE AND ADMINISTRATION

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

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.

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.

Cortane B_LBL_front Cortane B_LBL_back

CORTANE-B
hydrocortisone, pramoxine hcl, chloroxylenol lotion

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51674-0117-2	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/20/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		03/20/2017

Labeler - BLANSETT PHARMACAL CO (037477378)

Name	Address	ID/FEI	Business Operations
Establishment
BLANSETT PHARMACAL CO		037477378	manufacture(51674-0117)