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Cortane-B Lotion

Package insert / prescribing information
Generic name: hydrocortisone, pramoxine hydrochloride, chloroxylenol
Dosage form: lotion

Medically reviewed by Drugs.com. Last updated on Feb 21, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

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)
BLANSETT PHARMACAL CO

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