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Cortane-B Lotion

Generic Name: hydrocortisone, pramoxine hydrochloride, chloroxylenol
Dosage Form: lotion

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.

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 
hydrocortisone, pramoxine hcl, chloroxylenol lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL 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
1 NDC:51674-0117-2 60 mL in 1 BOTTLE
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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