NDC Code(s) : 58414-8960-1
Packager : NeoStrata Company Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PsorentCOAL TAR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58414-8960
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
COAL TAR(UNII: R533ESO2EC)
(COAL TAR - UNII:R533ESO2EC) 		COAL TAR23 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
OLETH-2(UNII: 7L6R1SQ6M0)
DIOCTYLDODECYL DODECANEDIOATE(UNII: 7QDB5EE79Y)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58414-8960-11 in 1 CARTON 17/07/2013
1100 mL in 1 BOTTLE, WITH APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part358H 07/17/2013 01/29/2019

PRINCIPAL DISPLAY PANEL

NeoStrata ®
therapeutics

PSORENT™
psoriasis
topical solution

Treatment and
Management

3.4 fl oz /100 ml

Principal Display Panel - 100 ml Bottle Carton