NDC Code(s) : 50544-100-11, 50544-100-94, 50544-101-10, 50544-101-94
Packager : University Medical Pharmaceuticals Corp

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AcneFree Severe Antibacterial Cleansing Wash Benzoyl Peroxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50544-100
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 Peroxide2.5 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
DISODIUM LAURETH SULFOSUCCINATE(UNII: D6DH1DTN7E)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCERIN(UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
LEVOMENOL(UNII: 24WE03BX2T)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
CHAMOMILE(UNII: FGL3685T2X)
PSEUDOPTEROGORGIA ELISABETHAE(UNII: UDY3H1OUX5)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
XANTHAN GUM(UNII: TTV12P4NEE)
CETYL ALCOHOL(UNII: 936JST6JCN)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
SODIUM BENZOATE(UNII: OJ245FE5EU)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50544-100-941 in 1 KIT
1NDC:50544-100-11118 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 12/21/2011
AcneFree Severe Maximum Strength Repair Lotion Benzoyl Peroxide LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50544-101
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 peroxide10 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERIN(UNII: PDC6A3C0OX)
LEVOMENOL(UNII: 24WE03BX2T)
BAKUCHIOL(UNII: OT12HJU3AR)
PANTHENOL TRIACETATE, (+)- (UNII: 1206E8961B)
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)
GINGER(UNII: C5529G5JPQ)
CHAMOMILE(UNII: FGL3685T2X)
NARINGENIN(UNII: HN5425SBF2)
PSEUDOPTEROGORGIA ELISABETHAE(UNII: UDY3H1OUX5)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
DIMETHICONE(UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
CETYL ALCOHOL(UNII: 936JST6JCN)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
EDETATE SODIUM(UNII: MP1J8420LU)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50544-101-941 in 1 KIT
1NDC:50544-101-1059 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 12/20/2011

PRINCIPAL DISPLAY PANEL

Severe to Clear Skin System
The ONLY TIME-RELEASED 10% Benzoyl Peroxide and Retinol System

The Most Powerful Acne-Healing Medicine Available Without A Prescription

Visible Clearing in Just Days Plus 24/7 Breakout Control
Medicine Stays in Pores to Continuously Fight Each Stage of Severe Acne
Dermatologist Tested - For All Ages and Skin Types

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