NDC Code(s) : 39765-005-01
Packager : Neutraderm, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acne Control Serum Benzoyl Peroxide GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39765-005
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE(UNII: W9WZN9A0GM)
(BENZOYL PEROXIDE - UNII:W9WZN9A0GM) 		BENZOYL PEROXIDE5 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCOLIC ACID(UNII: 0WT12SX38S)
BETASIZOFIRAN(UNII: 2X51AD1X3T)
ARNICA MONTANA FLOWER(UNII: OZ0E5Y15PZ)
ALLANTOIN(UNII: 344S277G0Z)
ECHINACEA PURPUREA(UNII: QI7G114Y98)
GOLDENSEAL(UNII: ZW3Z11D0JV)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP(UNII: 9YT4B71U8P)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
GLYCERIN(UNII: PDC6A3C0OX)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
SODIUM BENZOATE(UNII: OJ245FE5EU)
EDETATE SODIUM(UNII: MP1J8420LU)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
Product Characteristics
Color white (Off-White) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:39765-005-0130 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 07/01/2010

PRINCIPAL DISPLAY PANEL

Product Label