NDC Code(s) : 62191-014-09
Packager : Sunrider Manufacturing L.P.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nano CleanseBenzoyl Peroxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62191-014
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 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PEG-80 GLYCERYL COCOATE(UNII: A7D04GUR0Z)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
GLYCERIN(UNII: PDC6A3C0OX)
JUGLANS REGIA SHELL(UNII: PJ10MT7VKA)
COCAMIDOPROPYL BETAINE(UNII: 5OCF3O11KX)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
STEARIC ACID(UNII: 4ELV7Z65AP)
SHEA BUTTER(UNII: K49155WL9Y)
CETYL ALCOHOL(UNII: 936JST6JCN)
PEG-100 STEARATE(UNII: YD01N1999R)
XANTHAN GUM(UNII: TTV12P4NEE)
JOJOBA OIL(UNII: 724GKU717M)
GLYCOLIC ACID(UNII: 0WT12SX38S)
LINSEED OIL(UNII: 84XB4DV00W)
AVOCADO OIL(UNII: 6VNO72PFC1)
ALLANTOIN(UNII: 344S277G0Z)
TEA TREE OIL(UNII: VIF565UC2G)
DEANOL BITARTRATE(UNII: D240J05W14)
ALFALFA LEAF(UNII: HY3L927V6M)
AZELAIC ACID(UNII: F2VW3D43YT)
ROSEMARY(UNII: IJ67X351P9)
EVENING PRIMROSE OIL(UNII: 3Q9L08K71N)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW)(UNII: 1394NXB9L6)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)(UNII: J2S07SB0YL)
BARLEY(UNII: 5PWM7YLI7R)
TABASCO PEPPER(UNII: J1M3NA843L)
GARLIC(UNII: V1V998DC17)
ACAI(UNII: 46AM2VJ0AW)
FAGOPYRUM ESCULENTUM(UNII: B10M69172N)
LAVENDER OIL(UNII: ZBP1YXW0H8)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
CORN OIL(UNII: 8470G57WFM)
TOCOPHEROL(UNII: R0ZB2556P8)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
NORI(UNII: 477TV3P5UX)
PUMMELO(UNII: ET1TN5W71X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:62191-014-091 in 1 PACKAGE 08/04/2015
1248 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 08/04/2015

PRINCIPAL DISPLAY PANEL

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