CORTANE-B

CORTANE-B- hydrocortisone, pramoxine hydrochloride and 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.

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
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Cortane B_LBL_back
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CORTANE-B
hydrocortisone, pramoxine hcl, chloroxylenol lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51674-0117
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE 10 mg in 1 mL
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51674-0117-2 60 mL in 1 BOTTLE None
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 Operations
BLANSETT PHARMACAL CO 037477378 manufacture (51674-0117)

Revised: 03/2017 BLANSETT PHARMACAL CO

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