NDC Code(s) : 63433-897-97, 63433-897-10
Packager : DHC USA Incorporated

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DHC Acne Spot TherapySulfur CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63433-897
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sulfur(UNII: 70FD1KFU70)
(Sulfur - UNII:70FD1KFU70) 		Sulfur6 mg in 0.2 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Butylene Glycol(UNII: 3XUS85K0RA)
Isononyl Isononanoate(UNII: S4V5BS6GCX)
Cetostearyl Alcohol(UNII: 2DMT128M1S)
Sorbitan Monostearate(UNII: NVZ4I0H58X)
Polyoxyl 20 Cetostearyl Ether(UNII: YRC528SWUY)
Sucrose Cocoate(UNII: 3H18P0UK73)
Phenoxyethanol(UNII: HIE492ZZ3T)
Xanthan Gum(UNII: TTV12P4NEE)
Sodium Citrate, Unspecified Form(UNII: 1Q73Q2JULR)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Salicylic Acid(UNII: O414PZ4LPZ)
Magnesium Ascorbyl Phosphate(UNII: 0R822556M5)
Edetate Disodium(UNII: 7FLD91C86K)
Allantoin(UNII: 344S277G0Z)
.Alpha.-Tocopherol(UNII: H4N855PNZ1)
Sodium Hydroxide(UNII: 55X04QC32I)
Brassica Rapa Subsp. Oleifera Oil(UNII: N4G8379626)
Glycyrrhiza Glabra(UNII: 2788Z9758H)
Green Tea Leaf(UNII: W2ZU1RY8B0)
Royal Jelly(UNII: L497I37F0C)
Scutellaria Baicalensis Root(UNII: 7J95K7ID2S)
Perilla Frutescens Top(UNII: T4L5881Y68)
Houttuynia Cordata Flowering Top(UNII: RH041UUZ22)
Aloe Vera Leaf(UNII: ZY81Z83H0X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63433-897-9715 g in 1 TUBE Type 0: Not a Combination Product08/01/2011
2NDC:63433-897-101 g in 1 CELLO PACK Type 0: Not a Combination Product08/01/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 08/01/2011 11/12/2018

PRINCIPAL DISPLAY PANEL

DHC Acne Spot Therapy
Acne treatment
.52 oz. (15 g) Net wt.

DHC

Distributed by DHC USA Inc., San Francisco, CA 94107
Made in Japan • 1-800-DHC-CARE (342-2273)

PRINCIPAL DISPLAY PANEL - 15 g Tube Label