NDC Code(s) : 50718-0032-1
Packager : Kamedis

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clear Acne Spot TreatmentAcne Spot Treatment LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50718-0032
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID(UNII: O414PZ4LPZ)
(SALICYLIC ACID - UNII:O414PZ4LPZ) 		SALICYLIC ACID28.8 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
(C10-C30)ALKYL METHACRYLATE ESTER(UNII: XH2FQZ38D8)
ALCOHOL(UNII: 3K9958V90M)
PHELLODENDRON AMURENSE BARK(UNII: PBG27B754G)
SCUTELLARIA BAICALENSIS ROOT(UNII: 7J95K7ID2S)
BENZYL ALCOHOL(UNII: LKG8494WBH)
CAPRYLOYL GLYCINE(UNII: 8TY5YO42NJ)
CHLORPHENESIN(UNII: I670DAL4SZ)
CHRYSANTHEMUM INDICUM FLOWER(UNII: I6OER6U04L)
PURSLANE(UNII: M6S840WXG5)
GLYCERIN(UNII: PDC6A3C0OX)
RHEUM PALMATUM ROOT(UNII: G025DAL7CE)
SANGUISORBA OFFICINALIS ROOT(UNII: 4NYV2HT01X)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
PICEA ABIES WOOD(UNII: 72GZ8K8996)
PROPANEDIOL(UNII: 5965N8W85T)
SARCOSINE(UNII: Z711V88R5F)
HEXASODIUM PHYTATE(UNII: ZBX50UG81V)
TROMETHAMINE(UNII: 023C2WHX2V)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
CINNAMON BARK OIL(UNII: XE54U569EC)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50718-0032-11 in 1 CARTON 01/01/2018
122 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph drug M006 01/01/2018

LABELER - Kamedis(080311300)

Establishment
Name Address ID/FEI Business Operations
Biogenesis Inc. 069117328 manufacture(50718-0032)

PRINCIPAL DISPLAY PANEL

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